Industry News

Drugs.com – New Drug Approvals

• FDA Approves Tryptyr (acoltremon) Ophthalmic Solution for the Treatment of Dry Eye Disease
  May 28, 2025
• US Food and Drug Administration (FDA) Grants Interchangeability Designation to Samsung Bioepis and Organon Hadlima (adalimumab-bwwd) Injection
  May 27, 2025
• FDA Approves Starjemza (ustekinumab-hmny), a Biosimilar to Stelara
  May 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 Strengths
  May 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 Older
  May 22, 2025
• FDA Approves Genentech’s Susvimo for Diabetic Retinopathy
  May 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 Adults
  May 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 A
  May 19, 2025

Drugs.com – New Drug Applications

• Stealth BioTherapeutics Announces “Path Forward” Despite Disappointing Delay for Ultra-Rare Barth Syndrome
  May 29, 2025
• Patritumab Deruxtecan Biologics License Application for Patients with Previously Treated Locally Advanced or Metastatic EGFRMutated Non-Small Cell Lung Cancer Voluntarily Withdrawn
  May 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 Ataxia
  May 14, 2025
• Vanda Announces Bysanti NDA Filing; FDA Decision Expected in Early 2026
  May 5, 2025
• Cytokinetics Announces New PDUFA Date for Aficamten in Obstructive Hypertrophic Cardiomyopathy
  May 1, 2025
• Stealth BioTherapeutics Announces Delay in FDA Action Date for Barth Syndrome Application for Elamipretide
  April 29, 2025
• Kura Oncology and Kyowa Kirin Announce Submission of New Drug Application for Ziftomenib to FDA
  April 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 Disease
  April 3, 2025
• Vanda Pharmaceuticals Announces the Submission of an NDA to the FDA for Bysanti for the Treatments of Acute Bipolar I Disorder and Schizophrenia
  March 31, 2025

Drugs.com – Clinical Trials News

• Itepekimab Met Primary Endpoint in One of Two Chronic Obstructive Pulmonary Disease (COPD) Phase 3 Trials
  May 30, 2025
• NIH Scientists Pioneer Promising Treatment for Intractable Cancer Pain
  May 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 Sclerosis
  May 29, 2025
• Experimental Drug Development Centre Granted U.S. FDA Fast Track Designation for Antibody-Drug Conjugate EBC-129 to Treat Pancreatic Ductal Adenocarcinoma
  May 28, 2025
• Ocugen Announces Rare Pediatric Disease Designation Granted for OCU410ST – Modifier Gene Therapy for the Treatment of Stargardt Disease
  May 27, 2025
• Rocket Pharmaceuticals Provides Update on Phase 2 Clinical Trial of RP-A501 for Danon Disease
  May 27, 2025
• Teva Celiac Disease Candidate TEV-53408 Granted Fast Track Designation by US FDA
  May 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 Endpoint
  May 23, 2025
• Linvoseltamab in Combination with Carfilzomib or Bortezomib Shows Promising Initial Results in Earlier Lines of Treatment for Relapsed/Refractory Multiple Myeloma
  May 22, 2025