FDA grants BeOne Medicines a breakthrough therapy designation for sonrotoclax and its use in treating adults with relapsed or refractory mantle cell l...
FDA assigns an Official Action Indicated classification to a recent inspection of a Novo Nordisk manufacturing facility in Bloomington, IN.
AbbVie gains an updated label for Rinvoq (upadacitinib), expanding its use in treating adults with moderately to severely active ulcerative colitis an...
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...
