Industry News Drugs.com – New Drug Approvals 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 FDA Approves Aucatzyl (obecabtagene autoleucel) for Adults with Relapsed/Refractory B-Cell Acute Lymphoblastic LeukemiaNovember 8, 2024 FDA Approves Emrosi (minocycline hydrochloride) for the Treatment of RosaceaNovember 4, 2024 Shorla Oncology Announces U.S. FDA Expanded Approval of Jylamvo (methotrexate), an Oncology and Autoimmune Drug for Pediatric IndicationsOctober 29, 2024 Novartis Scemblix Granted FDA Accelerated Approval in Newly Diagnosed CMLOctober 29, 2024 Protega Pharmaceuticals Receives FDA Approval for RoxyBond (oxycodone hydrochloride) Immediate-Release 10 mg Tablet with Abuse-Deterrent Technology for Management of PainOctober 29, 2024 Drugs.com – New Drug Applications 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 Ionis Announces FDA Acceptance of New Drug Application for Donidalorsen for Prophylactic Treatment of HAENovember 4, 2024 Lexicon Announces Outcome of FDA Advisory Committee for Zynquista (sotagliflozin) as an Adjunct to Insulin Therapy for Glycemic Control in Adults with Type 1 Diabetes and Chronic Kidney DiseaseOctober 31, 2024 Verastem Oncology Completes Rolling NDA Submission to the FDA for Avutometinib Plus Defactinib as a Treatment for Recurrent KRAS Mutant Low-Grade Serous Ovarian CancerOctober 31, 2024 Drugs.com – Clinical Trials News Dapirolizumab Pegol Phase 3 Data Presented at the American College of Rheumatology Shows Significant Reduction in Systemic Lupus Erythematosus Disease ActivityNovember 19, 2024 Merck Announces Phase 3 Trial of Subcutaneous Pembrolizumab With Berahyaluronidase Alfa Met Primary EndpointsNovember 19, 2024 Cardiovascular Researchers Dramatically Reduce Size and Severity of Stroke Using Antidiabetic Drug in Preclinical ModelsNovember 19, 2024 Linerixibat Shows Positive Phase III Results in Cholestatic Pruritus in Primary Biliary Cholangitis (PBC)November 19, 2024 Open-Label Extension Data Confirms Sustained Benefit of Acoramidis on Cardiovascular Outcomes, Including Statistically Significant Reduction in ACM Within 36 MonthsNovember 18, 2024 Muvalaplin Lowered Lipoprotein(a) Levels in Adults with High Risk for Cardiovascular Events by up to 85% at Highest Tested DoseNovember 18, 2024 Arrowhead Pharmaceuticals Presents New Data at AHA24 from PALISADE Phase 3 Study and Open-Label Extension from MUIR and SHASTA-2 Studies of PlozasiranNovember 18, 2024 Icotrokinra Delivered an Industry-Leading Combination of Significant Skin Clearance with Demonstrated Tolerability in a Once Daily Pill in Phase 3 Topline ResultsNovember 18, 2024 New Alzheimer's prevention trial receives $74.5 million NIH grantNovember 14, 2024 Soligenix Initiates a Phase 2 Clinical Trial of SGX945 (dusquetide) for the treatment of Behçet's DiseaseNovember 14, 2024
