Drug Approval
The latest news about Drug Approval: headlines, AI summaries and the full story from every source.
- Roivant Sciences Reports Q2 2026 Results with LISRAYA Commercial Launch and Positive Clinical Data
- AbbVie Raises Full-Year Revenue Guidance Following Strong Immunology and Neuroscience Performance
- FDA Extends Review Period for Novo Nordisk's Denecimig Hemophilia Treatment
- MoonLake Immunotherapeutics Submits BLA for Sonelokimab to Treat Hidradenitis Suppurativa
- Genentech's Gazyva approved for idiopathic nephrotic syndrome
- Zenas BioPharma's Clinical Pipeline Faces Scrutiny Amid Rising Cash Burn
- Merck Receives Japanese Approval for Subcutaneous Version of Keytruda
- AstraZeneca-Daiichi Breast Cancer Drug Gets Approval in England
- Revolution Medicines Receives Approval for First Product RASONQUE in Pancreatic Cancer
- Scholar Rock's stock rises after FDA approves isembyld for spinal muscular atrophy
- Aquestive Therapeutics Advances Resubmission of Anaphylm to FDA
- FDA Approval of MIMRYLO Triggers $275M Payments for Protagonist
- FDA Accepts United Therapeutics' Application for Expanded Use of Nebulized Tyvaso
- FDA approves first RAS-targeted pancreatic cancer drug from Revolution Medicines
- Revolution Medicines Receives FDA Approval for Rasonque; Analysts Forecast $11.5 Billion Peak Sales
- Revolution Medicines Shares Drop Despite First FDA Approval
- U.S. FDA Approves Gilead's Once-Daily HIV Pill Bixlenvo
- Revolution Medicines Receives FDA Approval for Rasonque One Month After Filing
- Priovant Therapeutics Receives FDA Approval for Brepocitinib to Treat Dermatomyositis
- Zymeworks Shares Rise Ahead of FDA Decision on Zanidatamab
- FDA Accepts Label Expansion Application for Bristol-Myers and Merck's Anemia Therapy Reblozyl
- FDA Grants Priority Review for Johnson & Johnson's Expanded Use Application for Rybrevant Faspro
- Outlook Therapeutics Gets FDA Approval for LYTENAVA in Wet AMD Treatment
- Outlook Therapeutics receives FDA approval for Lytenava, the first ophthalmic bevacizumab for wet AMD
- FDA Accepts Dyne Therapeutics' BLA for Duchenne Muscular Dystrophy Treatment
- Outlook Therapeutics Receives July 29 PDUFA Date for LYTENAVA
- Larimar Therapeutics Submits First Module of BLA for Nomlabofusp Therapy
- Palvella Therapeutics Submits Initial Module of NDA for QTORIN
- FDA Accepts Bristol Myers' NDA for Mezigdomide Combo in Multiple Myeloma
- Agios Pharmaceuticals Stock Rises on FDA Priority Review for Mitapivat in Sickle Cell Disease
- Agios Pharmaceuticals Stock Rises on FDA Acceptance of Mitapivat Supplemental NDA
- FDA Extends Review Period for Praxis' Relutrigine Application
- Zambon and Amneal Receive Positive CHMP Opinion for Parkinson's Disease Treatment Hopledo®
- AbbVie's Skyrizi Approved in EU for Pediatric Plaque Psoriasis
- GSK and Spero Therapeutics Receive FDA Approval for First Oral Carbapenem Antibiotic for Complicated UTIs
- Alvotech Shares Rise as FDA Accepts BLA for Entyvio Biosimilar
- Dyne Therapeutics Submits Biologics License Application for Duchenne Treatment
- HUTCHMED Gains Attention Amid China Biotech Re-Rating
- Replimune Gains FDA Approval Submission After White House Intervention
- Gilead Sciences Wins FDA Approval for First HDV Treatment Hepcludex
- Gilead Sciences' Hepcludex Approved by FDA for Chronic HDV Infection
- ImmunityBio Stock Rises on FDA Acceptance for Anktiva Label Expansion
- AstraZeneca Receives FDA Approval for Hypertension Drug Baxfendy
- FDA Commissioner Defends Drug Approval Decisions Amid Backlash
- Corcept Therapeutics (CORT) Upgraded Following FDA Approval of Lifyorli for Ovarian Cancer
- AstraZeneca Receives FDA AdCom Recommendation for Truqap in Prostate Cancer Treatment
- AstraZeneca's Cancer Drug Faces FDA Advisory Panel Rejection
- Cullinan Therapeutics and Taiho Pharmaceutical Receive FDA Review for Cancer Therapy
- AbbVie Submits FDA Application for Subcutaneous Version of Skyrizi
- AbbVie Receives FDA CRL for Wrinkle Drug Due to Manufacturing Concerns