Industry News Drugs.com – New Drug Approvals Spravato (esketamine) Approved in the U.S. as the First and Only Monotherapy for Adults with Treatment-Resistant DepressionJanuary 21, 2025 FDA Approves Datroway (datopotamab deruxtecan-dlnk) for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast CancerJanuary 17, 2025 Calquence Plus Chemoimmunotherapy Approved in the U.S. for Patients with Previously Untreated Mantle Cell LymphomaJanuary 17, 2025 FDA Approves Lumakras (sotorasib) in Combination with Vectibix (panitumumab) for Chemorefractory KRAS G12C-Mutated Metastatic Colorectal CancerJanuary 17, 2025 FDA Approves Lilly's Omvoh (mirikizumab-mrkz) for Crohn's Disease, Expanding Its Use to the Second Major Type of Inflammatory Bowel DiseaseJanuary 15, 2025 Incyte and Syndax Announce U.S. Food and Drug Administration (FDA) Approval of Niktimvo (axatilimab-csfr) 9 mg and 22 mg Vial SizesJanuary 15, 2025 FDA Approves Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) Subcutaneous Injection for Use in Most Previously Approved Solid Tumor Opdivo (nivolumab) IndicationsDecember 27, 2024 Tevimbra Approved in U.S. for First-line Treatment of Gastric and Gastroesophageal Junction Cancers in Combination with ChemotherapyDecember 27, 2024 Sumitomo Pharma America Announces U.S. FDA Approval of Gemtesa (vibegron) for Men with Overactive Bladder Symptoms Receiving Pharmacological Therapy for Benign Prostatic HyperplasiaDecember 23, 2024 FDA Approves Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) for the Treatment of Cystic FibrosisDecember 20, 2024 Drugs.com – New Drug Applications Arrowhead Pharmaceuticals Announces Acceptance of New Drug Application by U.S. FDA of Plozasiran for the Treatment of Familial Chylomicronemia SyndromeJanuary 17, 2025 Atara Biotherapeutics Provides Regulatory and Business Update on Ebvallo (tabelecleucel)January 16, 2025 U.S. FDA Granted Priority Review to Dizal's Sunvozertinib New Drug ApplicationJanuary 7, 2025 Capricor Therapeutics Completes Submission of Biologics License Application to the U.S. FDA for Deramiocel for the Treatment of Duchenne Muscular DystrophyJanuary 2, 2025 Verastem Oncology Announces FDA Acceptance and Priority Review of New Drug Application for Avutometinib in Combination with Defactinib for the Treatment of Recurrent KRAS Mutant Low-Grade Serous Ovarian CancerDecember 30, 2024 Tonix Pharmaceuticals Announces PDUFA Goal Date of August 15, 2025, for FDA Decision on U.S. Marketing Approval for TNX-102 SL for FibromyalgiaDecember 23, 2024 Lexicon Announces Receipt of Complete Response Letter for Zynquista (sotagliflozin)December 20, 2024 PTC Therapeutics Announces Vatiquinone NDA Submission to FDA for the Treatment of Children and Adults Living with Friedreich AtaxiaDecember 19, 2024 U.S. Food and Drug Administration Issues Complete Response Letter for the Glepaglutide New Drug Application for the Treatment of Short Bowel SyndromeDecember 19, 2024 Merck Announces FDA Acceptance of Biologics License Application for Clesrovimab, an Investigational Long-Acting Monoclonal Antibody Designed to Protect Infants from RSV Disease During their First RSV SeasonDecember 17, 2024 Drugs.com – Clinical Trials News Dyne Therapeutics Receives FDA Fast Track Designation for DYNE-101 for the Treatment of Myotonic Dystrophy Type 1January 21, 2025 Boehringer Provides Update on Iclepertin Phase III Program in SchizophreniaJanuary 16, 2025 Adaptimmune Announces U.S. FDA Breakthrough Therapy Designation Granted to Letetresgene Autoleucel (lete-cel) for Treatment of Myxoid/Round Cell Liposarcoma (MRCLS)January 13, 2025 Datopotamab Deruxtecan Granted Priority Review in the US for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung CancerJanuary 13, 2025 Mersana Therapeutics Announces Additional FDA Fast Track Designation Granted to Emiltatug Ledadotin (XMT-1660)January 10, 2025 Research and Pipeline Research Pfizer’s Sasanlimab in Combination with BCG Improves Event-Free Survival in Patients with BCG-Naïve, High-Risk Non-Muscle Invasive Bladder CancerJanuary 10, 2025 Crinetics Announces Positive Topline Results From Phase 2 Trial of Atumelnant in Congenital Adrenal Hyperplasia (CAH)January 10, 2025 Nipocalimab Granted U.S. FDA Priority Review for the Treatment of Generalized Myasthenia GravisJanuary 9, 2025 Johnson & Johnson’s Posdinemab and Tau Active Immunotherapy Receive U.S. FDA Fast Track Designations for the Treatment of Alzheimer’s DiseaseJanuary 8, 2025 Mineralys Therapeutics Announces Phase 2 Clinical Trial of Lorundrostat for Obstructive Sleep Apnea in Patients with HypertensionJanuary 8, 2025
