Industry News Drugs.com – New Drug Approvals FDA Approves Tryptyr (acoltremon) Ophthalmic Solution for the Treatment of Dry Eye DiseaseMay 28, 2025 US Food and Drug Administration (FDA) Grants Interchangeability Designation to Samsung Bioepis and Organon Hadlima (adalimumab-bwwd) InjectionMay 27, 2025 FDA Approves Starjemza (ustekinumab-hmny), a Biosimilar to StelaraMay 27, 2025 FDA Approves Yutrepia (treprostinil) Inhalation Powder for Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)May 23, 2025 Celltrion's Yuflyma (adalimumab-aaty) Receives FDA Interchangeability Designation for All Approved Dosage Forms and StrengthsMay 23, 2025 Arcutis’ Zoryve (roflumilast) Topical Foam 0.3% Approved by U.S. FDA for the Treatment of Plaque Psoriasis in Adults and Adolescents Ages 12 and OlderMay 22, 2025 FDA Approves Genentech’s Susvimo for Diabetic RetinopathyMay 22, 2025 Nucala (mepolizumab) Approved by US FDA for Use in Adults with Chronic Obstructive Pulmonary Disease (COPD)May 22, 2025 FDA Approves Brekiya (dihydroergotamine mesylate) Injection for the Acute Treatment of Migraine and Cluster Headaches in AdultsMay 20, 2025 U.S. FDA Grants Approval for Jivi (Antihemophilic Factor (Recombinant), PEGylated-aucl) in Pediatric Patients 7 to Under 12 Years of Age With Hemophilia AMay 19, 2025 Drugs.com – New Drug Applications Stealth BioTherapeutics Announces “Path Forward” Despite Disappointing Delay for Ultra-Rare Barth SyndromeMay 29, 2025 Patritumab Deruxtecan Biologics License Application for Patients with Previously Treated Locally Advanced or Metastatic EGFRMutated Non-Small Cell Lung Cancer Voluntarily WithdrawnMay 29, 2025 Otsuka Announces FDA Acceptance and Priority Review of Biologics License Application (BLA) for Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)May 27, 2025 FDA Extends PDUFA Date of Biohaven's Troriluzole NDA for Rare Disease Spinocerebellar AtaxiaMay 14, 2025 Vanda Announces Bysanti NDA Filing; FDA Decision Expected in Early 2026May 5, 2025 Cytokinetics Announces New PDUFA Date for Aficamten in Obstructive Hypertrophic CardiomyopathyMay 1, 2025 Stealth BioTherapeutics Announces Delay in FDA Action Date for Barth Syndrome Application for ElamipretideApril 29, 2025 Kura Oncology and Kyowa Kirin Announce Submission of New Drug Application for Ziftomenib to FDAApril 8, 2025 Aldeyra Therapeutics Receives Complete Response Letter from the U.S. Food and Drug Administration for the Reproxalap New Drug Application for the Treatment of Signs and Symptoms of Dry Eye DiseaseApril 3, 2025 Vanda Pharmaceuticals Announces the Submission of an NDA to the FDA for Bysanti for the Treatments of Acute Bipolar I Disorder and SchizophreniaMarch 31, 2025 Drugs.com – Clinical Trials News Itepekimab Met Primary Endpoint in One of Two Chronic Obstructive Pulmonary Disease (COPD) Phase 3 TrialsMay 30, 2025 NIH Scientists Pioneer Promising Treatment for Intractable Cancer PainMay 29, 2025 Genentech’s Fenebrutinib Maintains Near-Complete Suppression of Disease Activity and Disability Progression for up to Two Years in People With Relapsing Multiple SclerosisMay 29, 2025 Experimental Drug Development Centre Granted U.S. FDA Fast Track Designation for Antibody-Drug Conjugate EBC-129 to Treat Pancreatic Ductal AdenocarcinomaMay 28, 2025 Ocugen Announces Rare Pediatric Disease Designation Granted for OCU410ST – Modifier Gene Therapy for the Treatment of Stargardt DiseaseMay 27, 2025 Rocket Pharmaceuticals Provides Update on Phase 2 Clinical Trial of RP-A501 for Danon DiseaseMay 27, 2025 Teva Celiac Disease Candidate TEV-53408 Granted Fast Track Designation by US FDAMay 27, 2025 Phase 3 Clinical Study of Mazdutide in Chinese Adults with Overweight or Obesity (GLORY-1) Published in The New England Journal of Medicine (NEJM)May 26, 2025 Prothena Announces Phase 3 AFFIRM-AL Clinical Trial for Birtamimab in Patients with AL Amyloidosis Did Not Meet Primary EndpointMay 23, 2025 Linvoseltamab in Combination with Carfilzomib or Bortezomib Shows Promising Initial Results in Earlier Lines of Treatment for Relapsed/Refractory Multiple MyelomaMay 22, 2025