FDA Calendar

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.

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.

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.