Browsing Tag
FDA
293 posts
Mabwell’s anti-ST2 antibody enters U.S. trials: Can 9MW1911 reshape immunotherapy for COPD?
Mabwell’s anti-ST2 antibody 9MW1911 enters U.S. trials after strong COPD data in China. Find out what this could mean for immunotherapy's future in COPD.
Hansa Biopharma targets Q3 2026 approval for imlifidase with Priority Review request
Hansa Biopharma submits imlifidase BLA to the FDA, aiming to transform access to kidney transplants for highly sensitized patients. Read more on what’s next.
Can J&J’s five-minute NSCLC injection disrupt the EGFR frontline market long ruled by osimertinib?
Johnson & Johnson’s five-minute NSCLC injection RYBREVANT FASPRO wins FDA approval. Learn how this subcutaneous delivery could reshape EGFR frontline therapy.
Can UPLIZNA transform gMG treatment? Amgen’s FDA win sets new benchmark for antibody-positive patients
Discover how Amgen’s UPLIZNA is redefining generalized myasthenia gravis treatment after FDA approval. Find out what this means for patients and investors.
BlinkRx collaboration positions Scienture’s Arbli for nationwide patient access in the $250+ million losartan market
Discover how Scienture and BlinkRx are expanding nationwide access to Arbli, the first FDA-approved liquid losartan, and what it means for the $250M hypertension market.
Lunit submits FDA filing for AI mammography model: What’s next for U.S. breast cancer screening?
Find out how Lunit’s FDA-bound artificial intelligence risk model could change breast cancer screening and prevention in the United States. Read the full story.
Dangerous glucose monitor readings spark FDA Class I recall: What went wrong with Abbott sensors?
Abbott’s FreeStyle Libre 3 sensors linked to 7 deaths and 700+ injuries. Find out what the FDA warns and what patients should do now.
Can 7.2 mg Wegovy redefine the weight loss standard in obesity treatment?
Novo Nordisk files for FDA approval of 7.2 mg Wegovy with fast-track priority review. See what this higher dose means for the future of obesity treatment.
What Vanda’s December FDA deadlines could mean for motion sickness drug market leadership
Vanda Pharmaceuticals confirms FDA extension of tradipitant clinical hold review to December 5, while motion sickness NDA remains on track for December 30 decision.
Hyrnuo secures FDA approval as Bayer expands precision oncology in HER2-driven lung cancer
FDA approval of Bayer’s Hyrnuo opens a new targeted option for HER2-mutated lung cancer patients—find out how this therapy is reshaping precision oncology today.