Industry News Drugs.com – New Drug Approvals FDA Approves Zepbound (tirzepatide) as the First and Only Prescription Medicine for Moderate-to-Severe Obstructive Sleep Apnea in Adults with ObesityDecember 20, 2024 FDA Approves Tryngolza (olezarsen) to Reduce Triglycerides in Adults with Familial Chylomicronemia SyndromeDecember 19, 2024 FDA Approves Ryoncil (remestemcel-L-rknd) Mesenchymal Stromal Cell Therapy for Steroid-Refractory Acute Graft Versus Host DiseaseDecember 18, 2024 FDA Approves Ensacove (ensartinib) for ALK-Positive Locally Advanced or Metastatic Non-Small Cell Lung CancerDecember 18, 2024 FDA Approves Steqeyma (ustekinumab-stba), a Biosimilar to StelaraDecember 17, 2024 FDA Approves Vtama (tapinarof) Cream for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and OlderDecember 16, 2024 Galderma Receives U.S. FDA Approval for Nemluvio (nemolizumab) for Patients with Moderate-to-Severe Atopic DermatitisDecember 15, 2024 FDA Approves Crenessity (crinecerfont) for the Treatment of Children and Adults with Classic Congenital Adrenal HyperplasiaDecember 15, 2024 FDA Approves Unloxcyt (cosibelimab-ipdl) for the Treatment of Cutaneous Squamous Cell CarcinomaDecember 13, 2024 FDA Approves Simplified Dosing Regimen for Acetadote (N-acetylcysteine for injection)December 9, 2024 Drugs.com – New Drug Applications 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 Tonix Pharmaceuticals Announces FDA Acceptance of the New Drug Application (NDA) for TNX-102 SL for FibromyalgiaDecember 17, 2024 Cytokinetics Announces FDA Acceptance of New Drug Application for Aficamten for the Treatment of Obstructive Hypertrophic CardiomyopathyDecember 2, 2024 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 Drugs.com – Clinical Trials News Nurix Therapeutics Receives U.S. FDA Fast Track Designation for NX-5948 for the Treatment of Relapsed or Refractory Waldenstrom’s MacroglobulinemiaDecember 19, 2024 Sapience Therapeutics Receives FDA Orphan Drug Designation for ST316, a First-in-Class β-catenin Antagonist, for the Treatment of Familial Adenomatous Polyposis (FAP)December 19, 2024 Reported Use of Most Drugs Among Adolescents Remained Low in 2024December 17, 2024 FDA Grants Fast Track Designation to Lipocine for LPCN 1148 as a Treatment for Sarcopenia in Patients with Decompensated CirrhosisDecember 17, 2024 Merck Provides Update on KeyVibe and KEYFORM Clinical Development Programs Evaluating Investigational Vibostolimab and Favezelimab Fixed-Dose Combinations with PembrolizumabDecember 16, 2024 Findings from Minzasolmin Proof-of-Concept ORCHESTRA Study Shape Next Steps in UCB Parkinson’s Research ProgramDecember 16, 2024 FDA Revokes Emergency Use Authorization (EUA) for Bebtelovimab for the Treatment of COVID-19December 13, 2024 FDA Revokes EUA for Sotrovimab for the Treatment of COVID-19December 13, 2024 FDA Revokes EUA for REGEN-COV (casirivimab and imdevimab) for the Treatment of COVID-19December 13, 2024 FDA Revokes EUA for Evusheld (tixagevimab co-packaged with cilgavimab) for the Treatment of COVID-19December 13, 2024
