Industry News

Drugs.com – New Drug Approvals

• FDA Approves Arbli (losartan potassium) Oral Suspension as the First Ready-to-Use Oral Liquid Losartan in the U.S.
  March 18, 2025
• ANI Pharmaceuticals Announces FDA Approval for Expansion of Iluvien Label
  March 14, 2025
• FDA Approves Omlyclo (omalizumab-igec), an Interchangeable Biosimilar to Xolair
  March 7, 2025
• scPharmaceuticals Announces FDA Approval of Supplemental New Drug Application Expanding the Furoscix Indication to Include the Treatment of Edema in Patients with Chronic Kidney Disease
  March 7, 2025
• FDA Approves Encelto (revakinagene taroretcel-lwey) for the Treatment of Macular Telangiectasia Type 2 (MacTel)
  March 6, 2025
• ARS Pharmaceuticals Announces FDA Approval of neffy 1 mg (epinephrine nasal spray) for Type I Allergic Reactions in Pediatric Patients
  March 5, 2025
• Tevimbra Approved in U.S. for First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma in Combination with Chemotherapy
  March 4, 2025
• FDA Approves TNKase (tenecteplase) for the Treatment of Acute Ischemic Stroke in Adults
  March 3, 2025
• FDA Approves Osenvelt (denosumab-bmwo), a Biosimilar to Xgeva
  March 3, 2025
• FDA Approves Stoboclo (denosumab-bmwo), a Biosimilar to Prolia
  March 3, 2025

Drugs.com – New Drug Applications

• Capricor Therapeutics Announces FDA Acceptance and Priority Review of its Biologics License Application for Deramiocel to Treat Duchenne Muscular Dystrophy
  March 4, 2025
• Depemokimab Applications Accepted for Review by the US FDA for Asthma with Type 2 Inflammation and for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
  March 3, 2025
• FDA Files Corcept’s New Drug Application for Relacorilant as Treatment for Patients With Hypercortisolism
  March 3, 2025
• Odronextamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Follicular Lymphoma
  February 26, 2025
• PTC Therapeutics Announces FDA Acceptance and Priority Review for Vatiquinone NDA for the Treatment of Children and Adults with Friedreich's Ataxia
  February 19, 2025
• Chimerix Announces FDA Acceptance and Priority Review of New Drug Application for Dordaviprone as Treatment for Recurrent H3 K27M-Mutant Diffuse Glioma
  February 18, 2025
• Biohaven Announces FDA Acceptance and Priority Review of Troriluzole New Drug Application for the Treatment of Spinocerebellar Ataxia
  February 11, 2025
• Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma
  February 11, 2025
• LIB Therapeutics Announces FDA Acceptance of Biologics License Application for Lerodalcibep to Lower LDL-Cholesterol Across Broad Patient Population
  February 10, 2025
• FDA Grants Priority Review to Insmed's Brensocatib for Treatment of Bronchiectasis with PDUFA Target Action Date Set for August 12, 2025
  February 6, 2025

Drugs.com – Clinical Trials News

• New Data on Investigational Therapy Doxecitine and Doxribtimine for Thymidine Kinase 2 Deficiency Presented at Muscular Dystrophy Association (MDA) 2025 Conference
  March 19, 2025
• Immunovant Announces Positive Results for Batoclimab Myasthenia Gravis (MG) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Studies
  March 19, 2025
• Henlius Receives Orphan-Drug Designation for HLX22 (Innovative anti-HER2 mAb) in the U.S. for Gastric Cancer
  March 19, 2025
• FDA Approved Compassionate Use Treatment with Namodenoson in a Pancreatic Cancer Patient
  March 18, 2025
• Sarepta Therapeutics Shares Safety Update on Elevidys
  March 18, 2025
• Signal12 Achieves FDA Alignment, Accelerating Pro-ocular™ Towards Phase 3 Clinical Trials for Ocular Graft-versus-Host Disease
  March 18, 2025
• Nipocalimab, the First and Only Investigational Treatment to be Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of Adults with Moderate-to-Severe Sjögren’s Disease, has now Received Fast Track Designation
  March 18, 2025
• vTv Therapeutics Announces FDA has Lifted Clinical Hold on Cadisegliatin Program for Diabetes
  March 17, 2025
• BioArctic Receives Orphan Drug Designation for Exidavnemab the US
  March 17, 2025
• Eneboparatide Met Primary Endpoint of Normalising Serum Calcium in Adults with Hypoparathyroidism at 24 weeks in CALYPSO Phase III Trial
  March 17, 2025