Regeneron says new clinical data show its investigational gene therapy DB-OTO has restored meaningful hearing in nearly all children treated for rare ...
FDA extends by three months its review of a Denali Therapeutics BLA for tividenofusp alfa, a potential treatment for Hunter syndrome.
FDA says it is monitoring reports of contaminated childrens cough and cold medicines manufactured in India but confirmed that the affected products di...
FDA approves Celltrions Eydenzelt (aflibercept-boav), a biosimilar referencing Regeneron and Bayers blockbuster Eylea for treating several major retin...
FDA approves new labeling for Janssen Biotechs Carvykti (ciltacabtagene autoleucel, including a Boxed Warning highlighting the risk of immune effector...
FDA approves SQ Innovations drug-device combination Lasix ONYU (furosemide injection) for treating edema (due to fluid overload) in adult patients wit...
Fifty-one Republican senators urge FDA to restrict access to abortion pills following the agencys recent approval of a new generic version of mifepris...
