Orchestra BioMed’s Hypertension Device Wins FDA Breakthrough Designation
Orchestra BioMed’s hypertension treatment is the latest medical device to earn the FDA’s breakthrough designation. The device is an atrio-ventricular ...
Thursday, May 1, 2025
Tag: FDA
Blockbuster Sanofi & Regeneron Drug Dupixent Notches FDA Nod for an Inflammatory Skin Disease
Sanofi and Regeneron Pharmaceuticals drug Dupixent has won FDA approval for chronic spontaneous urticaria, introducing a new approach to the ...
Novartis Nabs First FDA Nod in Rare Kidney Disease, But Apellis Pharma Is on Its Heels
An ultra-rare kidney disease that can become life-threatening now has its first FDA-approved therapy. The affirmative regulatory decision is the ...
Gene Therapy in an Implant: Neurotech Lands First FDA Approval in Rare Vision Disorder
Protein therapies for the eye must be dosed as frequent injections. Gene therapy offers one-time treatment, but must also be ...
Gen Z’s expensive drug habit: More want brand-name meds that are 79% more expensive
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FDA Approval of Drug for Rare Tumors Enables SpringWorks to Challenge AstraZeneca
A genetic disease that causes tumors to form on nerves has a new FDA-approved treatment, a SpringWorks Therapeutics drug that ...
“Precision Med Has Evolved as Badly As I Expected” And Other Takeaways From Former FDA Commissioner At PMWC
Former Food and Drug Administration Commissioner Robert Califf was in Silicon Valley to receive an award from The Precision Medicine ...
FDA recalls blood pressure drug after potentially fatal contamination | Morning in America
A Pennsylvania-based pharmaceutical firm and the FDA issued a recall of an injectable blood pressure medicine after a customer noticed ...
FDA Nod Paves Way for AstraZeneca Drug to Become New Standard of Care in Rare Blood Cancer
A blockbuster AstraZeneca drug may now be used as an earlier treatment for mantle cell lymphoma (MCL), making it the ...
FDA bans red dye No. 3 from foods, supplements, and some medicines because of potential cancer risk
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