FDA Calendar

Abivax SA provided an update on the progress of key clinical and preclinical programs and its leadership and operational updates.

Eton Pharmaceuticals, Inc announced the Company's New Drug Application (NDA) for ET-400, a proprietary patented formulation of hydrocortisone oral solution, has been accepted by the U.S. Food and Drug Administration (FDA)

Kyverna Therapeutics, Inc. announced that the designation as Regenerative Medicine Advanced Therapy (RMAT) by the U.S. Food and Drug Administration (FDA) for its autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate, KYV-101, to be used for the treatment of patients suffering from refractory stiff-person syndrome.

Artelo Biosciences, announced that the U.S. Food and Drug Administration (FDA) has issued a "Study May Proceed" letter for the Company's Investigational New Drug (IND) application for ART26.12, for the treatment of chemotherapy-induced peripheral neuropathy (CIPN).

Oncternal Therapeutics, Inc. announced that dosing initiated for the sixth dose cohort of its Phase 1/2 study of ONCT-534 for the treatment of patients with metastatic castration-resistant prostate cancer who are relapsed or refractory to approved androgen receptor pathway inhibitors (ARPI).

Oncternal Therapeutics, Inc. announced that announced that enrollment has been completed of Phase 1/2 Study of ONCT-534

Lexicon Pharmaceuticals, Inc announced that the Journal of Managed Care + Specialty Pharmacy (JMCP), the peer-reviewed journal of the Academy of Managed Care Pharmacy, has published a research paper concluding that the use of INPEFA® (sotagliflozin) for the treatment of patients hospitalized for heart failure (HF) and suffering from comorbid diabetes leads to significant positive impact on provider health system financial outcomes, largely due to bonus payments through alternative payment models (APM).

Checkpoint Therapeutics and GC Cell announced a collaboration to explore the combined therapeutic potential of cosibelimab, Checkpoint's anti-PD-L1 antibody with dual mechanism of action, with GC Cell's Immuncell-LC, an innovative autologous Cytokine Induced Killer ("CIK") T cell therapy composed of cytotoxic T lymphocytes and natural killer T cells.

Heron Therapeutics, Inc. announced that ZYNRELEF® (bupivacaine and meloxicam) is included in the proposed 2025 Non-Opioid Policy for Pain Relief under the Medicare hospital Outpatient Prospective Payment System ("OPPS") and the Medicare Ambulatory Surgical Center ("ASC") payment system (the "Proposed Rule") as a qualifying product effective April 1, 2025.

Pliant Therapeutics, Inc announced positive 24-week data from the 320 mg cohort of INTEGRIS-PSC, a multinational, randomized, double-blind, placebo-controlled Phase 2a clinical trial of bexotegrast in patients with primary sclerosing cholangitis (PSC) and suspected moderate to severe liver fibrosis.

ANI Pharmaceuticals, Inc. announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company launched L-Glutamine Oral Powder. ANI's L-Glutamine Oral Powder is the generic version of the reference listed drug (RLD) Endari®.

MIRA Pharmaceuticals, Inc announced promising new findings from recent preclinical studies of its novel oral pharmaceutical marijuana analog, MIRA-55, which is being studied as a potential treatment for anxiety and cognitive decline..

Acurx Pharmaceuticals, Inc. announced that results from the ibezapolstat (IBZ) Phase 2 clinical trial in patients with C. difficile Infection (CDI) were presented at the 17th Biennial Congress of the Anaerobe Society of the Americas on July 11th which was held at the University of Michigan, Ann Arbor, from July 8 to 11, 2024.

Benitec Biopharma Inc. announces continued durable improvements in the radiographic assessments of swallowing efficiency and the subject-reported outcome instrument as assessed at the 180-day timepoint following the administration of the low-dose of BB-301 to the study's first subject (Subject 1) treated in the BB-301 Phase 1b/2a single-arm, open-label, sequential, dose-escalation cohort study (NCT06185673) in Oculopharyngeal Muscular Dystrophy (OPMD).

Lexeo Therapeutics, Inc. announced positive interim data of LX2006 for the treatment of Friedreich ataxia (FA) cardiomyopathy. Across both the Lexeo SUNRISE-FA Phase 1/2 clinical trial (NCT05445323)

Lexeo Therapeutics, Inc. announced the Weill Cornell Medicine investigator-initiated Phase 1A trial (NCT05302271), LX2006 was well tolerated with no treatment-related serious adverse events, and clinically meaningful improvements in cardiac biomarkers were observed with increasing improvement over time.

GRAIL, Inc today provided an update on the PATHFINDER 2 and NHS-Galleri registrational clinical trials evaluating the Galleri® multi-cancer early detection (MCED) test. GRAIL has completed the PATHFINDER 2 study's planned enrollment of more than 35,000 participants who are eligible for guideline-recommended cancer screening at more than 30 healthcare institutions in North America.

GRAIL, Inc. announced that GRAIL Completes Final Study Visits for the NHS-Galleri Trial; Final Results Expected in 2026

Adagene Inc. announced a poster presentation at the upcoming ESMO Congress, taking place in Barcelona, Spain, 13-17 September 2024.

AbbVie announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for upadacitinib (RINVOQ®; 15 mg, once daily) for the treatment of adult patients with giant cell arteritis (GCA).

Verastem Oncology announced that the first patient has been dosed in a Phase 1/2 trial in China, conducted by GenFleet Therapeutics, evaluating GFH375/VS-7375, a KRAS G12D (ON/OFF) inhibitor.

Immutep Limited announces positive results from Cohort B of the TACTI-003 (KEYNOTE-PNC-34) Phase IIb trial evaluating eftilagimod alfa (efti) in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma patients (1L HNSCC) with negative PD-L1 expression.

Annexon, Inc. announced the Company will have two presentations at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting being held July 17-20, 2024 in Stockholm, Sweden.

- Inspira™ Technologies OXY announce the receipt of the Israeli Ministry of Health's medical devices and accessories ("AMAR") approval for the INSPIRA™ ART100, an Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass system.

Biodexa Pharmaceuticals PLC Announces Additional Positive Results Of Phase 2 Trial Of eRapa in Treatment Of Precancerous Polyps in the GI Tract - Now 12-Month Data

Daxor Corporation announces the expansion of blood volume analysis (BVA).

Acumen Pharmaceuticals, announced that the Company will present patient experience and biomarker data from its Phase 1 INTERCEPT-AD study of sabirnetug (ACU193) at the Alzheimer's Association International Conference (AAIC®) 2024 taking place in Philadelphia and online from July 28 – Aug. 1, 2024.

Lexeo Therapeutics, Inc announced that the company will conduct an investor webcast on Monday, July 15, 2024, at 8:00 AM ET to provide an interim clinical data update on LX2006, an AAVrh10.hFXN gene therapy for the treatment of Friedreich ataxia (FA) cardiomyopathy.

Palisade Bio, announced the successful completion of the first Good Manufacturing Practice (GMP) batch of its drug substance PALI-2108, an orally administered, locally acting colon-specific phosphodiesterase-4 (PDE4) inhibitor prodrug in development for patients affected by UC.

Pfizer Inc announced that based on results from the ongoing pharmacokinetic study (NCT06153758), the company has selected its preferred once-daily modified release formulation for danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist.

Can-Fite BioPharma announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for Orphan Drug Designation for its drug candidate Namodenoson in the treatment of pancreatic carcinoma.

Armata Pharmaceuticals, Inc. announced that it has achieved full enrollment in its Tailwind Phase 2 clinical study of inhaled AP-PA02 in patients with NCFB and chronic pulmonary Pseudomonas aeruginosa (P. aeruginosa) infection.

KalVista Pharmaceuticals, Inc. announced that it has submitted FDA Application for Sebetralstat

KalVista Pharmaceuticals, Inc announced that it has Phase 3 Trial Results Published

NanoViricides, Inc announced that a single drug that has shown activity against many respiratory viral infections in animal models, enabling human clinical trials for a number of indications.

Akebia Therapeutics®, announced key updates pertaining to the commercial launch of Vafseo® (vadadustat) Tablets. Akebia will host an investor conference call at 8:00 a.m. ET on Thursday, July 11, 2024.

Moleculin Biotech, Inc. announced the completion of its End of Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for its Phase 1B/2 clinical trial evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as AnnAraC) for the treatment of subjects with AML as both first line therapy and for subjects who are refractory to or relapsed after induction therapy (MB-106). ,

Ocuphire Pharma, Inc. announced it will participate in the Association for Research in Vision and Ophthalmology Special Interest Group (ARVO SIG) panel and the American Society of Retina Specialists (ASRS) 42nd Annual Scientific Meeting, to highlight the potential of its lead oral candidate in development for diabetic retinopathy (DR).

Oragenics, Inc announced it has developed a new formulation for its novel neurosteroid. Oragenics' lead drug candidate for concussion, ONP-002, is a new chemical entity (NCE) designed to target the brain through delivery into the nasal cavity and onward to the brain.

Ocular Therapeutix, Inc. announced that a late-breaking abstract related to the Phase 1 HELIOS study of AXPAXLI (axitinib intravitreal implant) for non-proliferative diabetic retinopathy (NPDR) was accepted for presentation at the 42nd American Society of Retina Specialists (ASRS) Annual Scientific Meeting being held July 17-20 in Stockholm, Sweden.

Ovid Therapeutics Inc. announced that eNeuro, a peer-reviewed, open-access journal from the Society for Neuroscience published several preclinical studies validating OV329's mechanism of action and anti-convulsant properties.

Adverum Biotechnologies, Inc announced that the company will host a webcast to review the interim 26-week landmark data from its ongoing LUNA Phase 2 study of ixoberogene soroparvovec (Ixo-vec) for the treatment of wet age-related macular degeneration (wet AMD) being presented at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting.

Virpax® Pharmaceuticals, Inc. announced results for a Swine Model pilot study for Probudur, Virpax's long-acting liposomal bupivacaine formulation injected at a wound site to provide both immediate and extended pain relief.

Kazia Therapeutics Limited is pleased to announce results from GBM-AGILE, a phase II/III study that included an evaluation of paxalisib versus standard of care (SOC) for patients with glioblastoma (NCT03522298), a life-threatening brain cancer, where there is an urgent unmet need for new therapeutics.

Longeveron Inc. announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to Lomecel-B™ for the treatment of mild Alzheimer's Disease.

Unicycive Therapeutics, announced the initial results from the patient reported outcome survey conducted during the UNI-OLC-201 pivotal clinical trial.

OKYO Pharma announced promising new categorical data analyses from the recent OK-101 Phase 2 trial in DED patients.

United Therapeutics Corporation announced full enrollment of the TETON 2 study evaluating the use of Tyvaso® (treprostinil) inhalation solution (nebulized Tyvaso) for the treatment of idiopathic pulmonary fibrosis (IPF).

Arcutis Biotherapeutics announced the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for ZORYVE (roflumilast) cream, 0.15%, for the treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. ZORYVE is a once-daily, steroid-free cream that provides rapid disease clearance and significant reduction in itch and has been specifically developed to be a treatment option for long-term disease control.

IGC Pharma, Inc announced preclinical data demonstrating TGR-63's potential as an effective treatment for Alzheimer's disease

Microbot Medical Inc announced that Baptist Hospital of Miami, which includes Miami Cardiac & Vascular Institute and Miami Cancer Institute, has completed its first clinical procedure in a patient utilizing the LIBERTY® Endovascular Robotic Surgical System. .

Kiniksa Pharmaceuticals announced that it has commenced enrollment of the Phase 2b clinical trial of abiprubart in Sjögren's Disease. Abiprubart is an investigational humanized anti-CD40 monoclonal antibody designed to inhibit CD40-CD154 (CD40 ligand) interaction.

AEON Biopharma, Inc announced plans to advance a single pivotal clinical development study in cervical dystonia ("CD") for its lead candidate, ABP-450 (prabotulinumtoxinA) injection, utilizing the 351(k) regulatory pathway for biosimilars with the market leader, BOTOX® (onabotulinumtoxinA), as the reference product.

Reviva Pharmaceuticals announced European Patent EP3244896 has been granted by the European Patent Office (EPO) covering use of brilaroxazine for the treatment of PH, adding to its existing patent protection in key markets around the world including the United States, China and Japan.

Soligenix, Inc announced an interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte™ treatment for up to 12 months in patients with early-stage cutaneous T-cell lymphoma (CTCL).

uniQure N.V announced updated interim data including up to 24 months of follow-up data from 29 treated patients enrolled in the ongoing U.S. and European Phase I/II clinical trials of AMT-130 for the treatment of Huntington's disease.

Harrow announced that as of July 1, 2024, it has entered into an agreement with Apexus to make IHEEZO® (chloroprocaine hydrochloride ophthalmic gel) 3% and other Harrow products available through its 340B Prime Vendor Program.

BioCryst Pharmaceuticals, Inc announced that the General Directorate of Medicines, Supplies and Drugs (DIGEMID) in Peru has granted approval for oral, once-daily ORLADEYO® (berotralstat) for the prophylaxis of hereditary angioedema (HAE) attacks in adults and pediatric patients 12 years of age or older.

Avalo expects to enroll the first patient in its Phase 2 LOTUS Trial this year.

Avalo Therapeutics, Inc announced that the Investigational New Drug (IND) for AVTX-009, an anti-IL-1β monoclonal antibody (mAb), for the treatment of hidradenitis suppurativa (HS) is now active, permitting the Company to commence its Phase 2 (LOTUS) clinical trial in patients with HS.

60 Degrees Pharmaceuticals, announced ethics approval of an open label, expanded access study of the ARAKODA® regimen of tafenoquine in combination with standard of care regimens in immunosuppressed patients with persistent/relapsing babesiosis.

ANEW MEDICAL, INC announces plans to advance its recently patented Klotho gene therapy program for neurodegenerative disorders.

Mesoblst Limited announced it has resubmitted its BLA for approval of Ryoncil® (remestemcel-L) in the treatment of children with SR-aGVHD.

Kymera Therapeutics, announced that following a review of preliminary KT-474 safety and efficacy data by an Independent Data Review Committee, Sanofi has informed Kymera that it intends to expand the ongoing Hidradenitis Suppurativa (HS) and Atopic Dermatitis (AD) Phase 2 trials to more rapidly progress towards pivotal studies.

Revolution Medicines, announced that it will host an investor webcast to provide an update on its RMC-6236 pancreatic ductal adenocarcinoma (PDAC) clinical development program. Speakers will include members of Revolution Medicines' management team, along with Brian M. Wolpin, M.D., M.P.H., professor of medicine at Harvard Medical School, and director of the Gastrointestinal Cancer Center and Robert T. & Judith B. Hale Chair in Pancreatic Cancer at Dana-Farber Cancer Institute.

Immix Biopharma, Inc announced that the 1st patient has been dosed at MSKCC in its U.S. NEXICART-2 trial with NXC-201, a sterically-optimized BCMA-targeted CAR-T cell therapy..

HilleVax, Inc announced topline data results from NEST-IN1. NEST-IN1 is a Phase 2b, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy, safety, and immunogenicity of HIL-214 in infants of approximately 5 months of age at the time of initial vaccination at sites in the United States and Latin America.

Silo Pharma, Inc. announced that it has entered into an exclusive, global license agreement with Columbia University to further develop, manufacture, and commercialize its lead drug candidate, SPC-15, an intranasal treatment for stress-induced affective disorders and PTSD.

SELLAS Life Sciences Group, Inc. announced that the European Commission, based on a positive opinion issued by the European Medicines Agency (EMA), has granted Orphan Drug Designation (ODD) for SLS009, a novel, and highly selective CDK9 inhibitor, for the treatment of acute myeloid leukemia (AML).

Mirum Pharmaceuticals, Inc announced that the European Commission has granted marketing authorization for LIVMARLI® (maralixibat) oral solution for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients three months of age and older.

Microbot Medical Inc. announced the completion of the first procedure in a patient utilizing its LIBERTY® Endovascular Robotic Surgical System.

Outlook Therapeutics, Inc. announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for LYTENAVA™ (bevacizumab gamma), an ophthalmic formulation of bevacizumab for the treatment of wet AMD in the UK.

CERo Therapeutics Holdings, Inc. announces presentation of a poster on its lead compound CER-1236 at the Global Cell & Gene Therapy Summit 2024. The conference is being held July 8-10 in Boston.

Tonix Pharmaceuticals announced receipt of the formal minutes from a recent pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia.

Pulse Biosciences, Inc announced that it has received the Breakthrough Device Designation from the U.S. FDA for the Company's Cardiac Surgery System for the ablation of cardiac tissue for the treatment of atrial fibrillation (AF).

Amarin Corporation plc announced that its commercial partner in Mainland China ("China"), EddingPharm (EDDING), has received regulatory approval for VASCEPA® (icosapent ethyl) from China's National Medical Products Administration (NMPA).

Adicet Bio, Inc. announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-270 for the potential treatment of patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC) who have been treated with an immune checkpoint inhibitor and a vascular endothelial growth factor inhibitor.

IDEAYA Biosciences, announced positive clinical data for the IDE397 Phase 2 monotherapy expansion dose in methylthioadenosine phosphorylase (MTAP)-deletion urothelial and non-small cell lung cancer (NSCLC) patients.

IDEAYA Biosciences announced that the company plans to issue a pre-market press release and conduct an investor webcast on Monday, July 8, 2024, at 8:00 a.m. EST to provide a clinical data update for the IDE397 Phase 2 monotherapy expansion dose in MTAP-deletion urothelial and non-small cell lung cancer (NSCLC) patients.

Inventiva provided an update on its clinical program evaluating lanifibranor for the treatment of MASH/NASH and its financial position.

AstraZeneca’s Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy has been approved in the European Union (EU) for the 1st-line treatment of adult patients with advanced epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations.

Roche Group announced the U.S. Food and Drug Administration (FDA) has approved the Vabysmo® (faricimab-svoa) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of wet, or neovascular, age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO).

Calliditas Therapeutics AB announces that its partner Viatris Pharmaceutical Japan G.K. ("Viatris") has initiated a phase III clinical trial in Japan with Nefecon, named VR-205 in the Japanese market, in Japanese patients with IgA nephropathy (IgAN).

Roche Group that the Phase II/III SKYSCRAPER-06 study, evaluating tiragolumab plus Tecentriq® (atezolizumab) and chemotherapy versus pembrolizumab and chemotherapy as an initial (first-line) treatment for people with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (nSq NSCLC), did not meet its primary endpoints of progression-free survival (PFS) at its primary analysis with a hazard ratio (HR) of 1.27 [95% CI: 1.02,1.57] and overall survival (OS) at its first interim analysis with a HR of 1.33 [95% CI: 1.02, 1.73], which was immature.

HUTCHMED (China) Limited announces that the New Drug Application ("NDA") for tazemetostat for the treatment of adult patients with relapsed or refractory ("R/R") follicular lymphoma ("FL") has been accepted for review and granted Priority Review by the China National Medical Products Administration ("NMPA").

SeaStar Medical Holding announces that the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has agreed to the final labeling for SeaStar Medical's QUELIMMUNE™, the Selective Cytopheretic Device for pediatric patients, paving the way under the Humanitarian Use Device (HUD) designation to market the therapeutic device in the U.S. for the treatment of children weighing 10 kilograms or more with acute kidney injury (AKI) and sepsis or septic condition requiring kidney replacement therapy (KRT).

Artelo Biosciences announced several presentations about ART12.11, Artelo's proprietary cocrystal combination drug candidate, were delivered at the 34th Annual International Cannabinoid Research Society (ICRS) Symposium held June 30 through July 5, 2024 in Salamanca, Spain.

Immutep Limited announces details for an upcoming oral presentation at the European Society for Medical Oncology (ESMO) Virtual Plenary session on July 11, 2024, featuring new clinical data in patients with negative PD-L1 expression (Cohort B) in the TACTI-003 (KEYNOTE-PNC-34) Phase IIb trial, and a webcast to discuss these clinical results.

Johnson & Johnson announced that that Health Canada, through a Priority Review, has issued a Notice of Compliance (NOC) for RYBREVANT® (amivantamab) in combination with platinum-based chemotherapy (carboplatin and pemetrexed) for the first-line treatment of adult patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 20 insertion mutations.1

Regeneron Pharmaceuticals, Inc announced that the European Commission (EC) has approved Dupixent® (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils.

Gyre Therapeutics announced that China's National Medical Products Administration ("NMPA") has approved Gyre Pharmaceuticals' (Gyre's indirectly controlled subsidiary) avatrombopag maleate tablets for the treatment of thrombocytopenia ("TP") associated with chronic liver disease ("CLD") in adult patients undergoing elective diagnostics procedures or therapy.

Tyra Biosciences, Inc. announced preclinical proof-of-concept results with TYRA-300, an investigational oral FGFR3 selective inhibitor, in hypochondroplasia (HCH).

Eli Lilly announced that The U.S. Food and Drug Administration (FDA) approved Kisunla™ (donanemab-azbt, 350 mg/20 mL once-monthly injection for IV infusion)

Alvotech announced positive topline results from a confirmatory patient study for AVT03, a proposed biosimilar to Prolia® (denosumab) and Xgeva® (denosumab).

Vertex used a priority review voucher for this submission reducing the review time from 10 months to 6 months, resulting in a Prescription Drug User Fee Act (PDUFA) target action date of January 2, 2025.

Vertex Pharmaceuticals Incorporated announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for investigational once-daily vanzacaftor/tezacaftor/deutivacaftor triple combination therapy (vanza triple) for people living with cystic fibrosis (CF) ages 6 years and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene responsive to the vanza triple.

Inozyme Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to INZ-701 for the treatment of ABCC6 Deficiency.

Biodexa Pharmaceuticals PLC announces data from a Phase 1 study of MTX110 in Diffuse Midline Glioma ("DMG") f/k/a Diffuse Intrinsic Pontine Glioma, or DIPG, an orphan pediatric brain cancer were presented over the weekend at the 21st International Symposium on Pediatric Neuro-Oncology (ISPNO 2024) in Philadelphia, PA.

Heron Therapeutics, Inc. announced that the FDA acknowledged the receipt of the Company's Prior Approval Supplement ("PAS") application for ZYNRELEF® (bupivacaine and meloxicam) extended-release solution VAN.

Annovis Bio Inc. announced new data from its Phase III PD study demonstrating that buntanetap is safe and effective in improving motor and non-motor activities and improving cognitive functions in patients with early Parkinson's disease.

Lucid Diagnostics subsidiary of PAVmed Inc announced positive data from its ESOGUARD BE-1 prospective, international, multicenter, single-arm study conducted to clinically validate performance of the EsoGuard® Esophageal DNA test on samples collected with the EsoCheck® Esophageal Cell Collection Device for detection of esophageal precancer (Barrett's Esophagus or BE) and esophageal adenocarcinoma (EAC) in a screening population.

Cognition Therapeutics, announced that abstracts summarizing clinical efficacy, safety and biomarker findings from the Phase 2 COG0201 "SHINE" study of CT1812 have been accepted for poster presentation at the upcoming Alzheimer's Association's International Conference being held in Philadelphia, PA from July 28-August 1, 2024.

Johnson & Johnson announced positive results from a prespecified second interim analysis of the Phase 3 CARTITUDE-4 study evaluating CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) compared to standard therapies of pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) for the treatment of patients with relapsed or lenalidomide-refractory multiple myeloma after one prior line of therapy.

Checkpoint Therapeutics announced it has completed the resubmission of its Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA") for cosibelimab, its anti-programmed death ligand-1 ("PD-L1") antibody, as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC") who are not candidates for curative surgery or curative radiation.,

Ardelyx, Inc announced that, in an effort to preserve patient access to its phosphate absorption inhibitor XPHOZAH® (tenapanor), the Company has chosen not to apply to include XPHOZAH in the Centers for Medicare & Medicaid Services (CMS) End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Transitional Drug Add-on Payment Adjustment (TDAPA).

KORU Medical Systems, Inc announced that its state-of-the-art FreedomEdge® System has received regulatory clearance in Japan for the delivery of multiple drugs, including CSL Behring's Hizentra subcutaneous immunoglobulin (SCIg), Takeda Pharmaceutical's Cuvitru SCIg, and Sobi's Aspaveli paroxysmal nocturnal hemoglobinuria (PNH).

ANI Pharmaceuticals, Inc. announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) and launched Naproxen Delayed-Release Tablets, USP. ANI's Naproxen Delayed-Release Tablets is the generic version of the reference listed drug (RLD) EC-Naprosyn®.

Cartesian Therapeutics announced positive topline results from its Phase 2b trial of Descartes-08 in patients with generalized myasthenia gravis (MG).

Immuron Limited announce that it has filed a pre-IND (investigational new drug) application with the United States Food and Drug Administration (FDA) for IMM-529.

Longboard Pharmaceuticals, Inc announced that the FDA has granted Breakthrough Therapy designation for its investigational drugbexicaserin for the treatment of seizures associated with Developmental and Epileptic Encephalopathies (DEEs) for patients two years of age or older.

BrainStorm Cell Therapeutics Inc. announced that that it will hold a mid-year corporate update to discuss recent positive developments in the NurOwn® program on Monday, July 8, at 8:00 a.m. U.S. Eastern Time

Neurocrine Biosciences, Inc. announced the U.S. Food and Drug Administration (FDA) has accepted its two New Drug Applications (NDA) with Priority Review designations for crinecerfont in the treatment of children, adolescents and adults with classic congenital adrenal hyperplasia (CAH).

Biora Therapeutics, Inc. shared positive topline results from its clinical trial of BT-600, an orally administered drug-device combination in development for the potential treatment of patients with ulcerative colitis (UC).

Ovid Therapeutics Inc. announced the results from their Phase 1 healthy volunteer study evaluating the safety, tolerability, and pharmacokinetic (PK) profile of multiple ascending doses of OV888/GV101 capsule.

NeuroSense Therapeutics Ltd. reported statistically significant results from the 12-month data analysis of the PARADIGM Phase 2b study evaluating PrimeC in people living with Amyotrophic Lateral Sclerosis (ALS).

Humacyte, Inc. announced that it has been granted the U.S. Food and Drug Administration's (FDA's) Regenerative Medicine Advanced Therapy (RMAT) designation for patients with advanced peripheral artery disease (PAD).

Can-Fite BioPharma Ltd. announced that that a patient with liver decompensated cirrhosis who was treated with Namodenoson at the Soroka Medical Center in Israel under compassionate use showed an improvement in liver indices.

SpringWorks Therapeutics, Inc announced that the Company has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for mirdametinib, an investigational MEK inhibitor, for the treatment of pediatric and adult patients with neurofibromatosis type 1- associated plexiform neurofibromas (NF1-PN).

AstraZeneca’s Marketing Authorisation Application (MAA) for sipavibart has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA), for the pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised patients.

Mesoblast Limited confirmed that it will file its Biologics License Application (BLA) for approval of Ryoncil® (remestemcel-L) in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD) with the U.S. Food and Drug Administration (FDA) next week.