Industry News Drugs.com – New Drug Approvals FDA Grants Accelerated Approval to Bizengri (zenocutuzumab-zbco) for NRG1+ Pancreatic Adenocarcinoma and NRG1+ Non–Small Cell Lung CancerDecember 4, 2024 FDA Approves Yesintek (ustekinumab-kfce), a Biosimilar to StelaraDecember 1, 2024 FDA Approves Rapiblyk (landiolol) for Atrial Fibrillation and Atrial Flutter in the Critical Care SettingNovember 27, 2024 FDA Approves Imkeldi (imatinib) Oral Solution for the Treatment of Certain Forms of Leukemia and Other CancersNovember 25, 2024 FDA Approves Attruby (acoramidis) to Reduce Cardiovascular Death and Cardiovascular-Related Hospitalization in Patients with ATTR-CMNovember 22, 2024 FDA Grants Accelerated Approval to Ziihera (zanidatamab-hrii) for the Treatment of HER2-Positive Biliary Tract CancerNovember 20, 2024 UCB Receives U.S. FDA Approval for Bimzelx (bimekizumab-bkzx) as the First IL-17A and IL-17F Inhibitor for Adults with Moderate to Severe Hidradenitis SuppurativaNovember 20, 2024 FDA Approves Revuforj (revumenib) for the Treatment of Adult and Pediatric Patients with Relapsed or Refractory Acute Leukemia with a KMT2A TranslocationNovember 15, 2024 FDA Approves Danziten (nilotinib) Tablets, the First and Only Nilotinib With No Mealtime RestrictionsNovember 14, 2024 FDA Approves Kebilidi (eladocagene exuparvovec-tneq) Gene Therapy for the Treatment of AADC DeficiencyNovember 13, 2024 Drugs.com – New Drug Applications Applied Therapeutics Receives Complete Response Letter from U.S. FDA Regarding New Drug Application for Govorestat for Classic GalactosemiaNovember 27, 2024 Satsuma Pharmaceuticals and SNBL Receive FDA Acceptance of NDA Resubmission of STS101 for the Acute Treatment of Migraine With or Without AuraNovember 26, 2024 Soleno Therapeutics Announces FDA Extension of Review Period for DCCR (Diazoxide Choline) Extended-Release Tablets in Prader-Willi SyndromeNovember 26, 2024 Arrowhead Pharmaceuticals Submits New Drug Application to U.S. FDA for Plozasiran for the Treatment of Familial Chylomicronemia SyndromeNovember 18, 2024 Aldeyra Therapeutics Announces FDA Acceptance for Review of Reproxalap New Drug Application for the Treatment of Dry Eye DiseaseNovember 18, 2024 Abeona Therapeutics Announces FDA Acceptance of BLA Resubmission of Pz-cel for the Treatment of Recessive Dystrophic Epidermolysis BullosaNovember 12, 2024 Datopotamab Deruxtecan New BLA Submitted for Accelerated Approval in the US for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung CancerNovember 12, 2024 Unicycive Therapeutics Announces U.S. FDA Acceptance of the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on DialysisNovember 11, 2024 Dizal Submits New Drug Application to the U.S. FDA for Sunvozertinib in Treating Relapsed or Refractory Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion MutationsNovember 8, 2024 Merus Receives FDA Extension of PDUFA for ZenocutuzumabNovember 5, 2024 Drugs.com – Clinical Trials News Syros Announces Topline Data from SELECT-MDS-1 Phase 3 Trial of Tamibarotene in Higher-Risk Myelodysplastic Syndrome with RARA Gene OverexpressionDecember 4, 2024 FDA Grants Breakthrough Therapy Designation to Sacituzumab Tirumotecan (sac-TMT) for the Treatment of Certain Patients With Previously Treated Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer With EGFR MutationsDecember 3, 2024 Lantern Pharma's Investigational Drug-Candidate, LP-184, Receives Second Fast Track Designation from FDA for Treatment of Triple Negative Breast Cancer (TNBC)December 3, 2024 Aquestive Therapeutics Announces Positive FDA Feedback and Reaffirms NDA Submission Guidance for Anaphylm (epinephrine) Sublingual FilmDecember 2, 2024 Newer Epilepsy Medications Used During Pregnancy Do Not Affect Neurological Development in ChildrenNovember 27, 2024 Lin BioScience Receives U.S. FDA Fast Track Designation For LBS-007November 27, 2024 Amgen Announces Robust Weight Loss With MariTide in People Living With Obesity or Overweight at 52 Weeks in a Phase 2 StudyNovember 26, 2024 Axsome Therapeutics Announces AXS-12 Achieves Primary Endpoint in ENCORE Long-Term Phase 3 Trial in NarcolepsyNovember 26, 2024 Cassava Sciences Topline Phase 3 Data for Simufilam Did Not Meet Co-Primary EndpointsNovember 25, 2024 Biohaven Provides Update on Taldefgrobep Alfa Development Program for Spinal Muscular Atrophy and ObesityNovember 25, 2024
