fda-and-biotech News
Medtronic Slips as FDA Assigns 'Most Serious' Risk to Heart Device Recall
The Class I designation for its DLP Left Heart Vent Catheter follows reports of three serious injuries, renewing scrutiny on the medical device giant's quality controls.
Agios Dips Despite Landmark FDA Approval for Thalassemia Drug
AQVESME becomes the first and only approved therapy for anemia in both alpha- and beta-thalassemia, yet shares fell in a classic 'sell the news' reaction.
Edwards Lifesciences Gains FDA Nod for First-of-its-Kind Mitral Valve
The approval for the SAPIEN M3 system opens a new, non-surgical treatment market for patients with severe mitral regurgitation, bolstering the firm's leadership in structural heart therapies.
Sanofi Stumbles as FDA Rejects Key Multiple Sclerosis Drug
The complete response letter for tolebrutinib marks a significant blow to the French drugmaker's neurology pipeline and a drug once seen as a potential blockbuster.
Organogenesis Gains on FDA Filing for Novel Knee Osteoarthritis Therapy
The company initiated a rolling Biologics License Application for its ReNu therapy, targeting a 31 million patient market and signaling a major push beyond its core wound-care business.
Invivyd Stock Soars 25% on FDA Fast Track for COVID Antibody
Key clinical and regulatory milestones achieved for VYD2311, an antibody alternative to vaccines, as company initiates pivotal Phase 3 trial.
Novo Nordisk Soars on FDA Approval of Oral Wegovy Pill
The decision clears the path for the first pill-based GLP-1 treatment for weight management, intensifying the rivalry with Eli Lilly in the lucrative obesity market.
Amneal Shares Hit 52-Week High on FDA Biosimilar Approval
The drugmaker gains FDA approval for two biosimilars targeting blockbuster drugs Prolia and XGEVA in a U.S. market worth over $5 billion annually.