Roche has received the US Food and Drug Administration (FDA) priority review for its supplemental biologics licence application (sBLA) for adjuvant Tecentriq (atezolizumab) and Tecentriq Hybreza ...

Marina is that curiosity, a cult female star making pop music. Unlike most female pop stars of her longevity, she’s never had one of those monster hits that everyone knows. She has no “Poker Face”, ...

A Prescription Drug User Fee Act target date of September 30, 2026 has been set for the application. The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug ...

A Prescription Drug User Fee Act target date of November 30, 2026 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application ...

Cogent Biosciences (COGT) is poised for two product launches later this year after the FDA granted priority review for its marketing application for its lead candidate, bezuclastini, for a rare form ...

In the phase 3 OCEANIC-STROKE trial, asundexian significantly reduced recurrent ischemic stroke risk compared with placebo without significantly increasing major bleeding. The Food and Drug ...

(Corrects May 21 story to clarify finerenone is currently used to treat type 2, not type 1 diabetes, in second paragraph) May 21 (Reuters) - Bayer said on Thursday that the U.S. Food and Drug ...

Bayer (BAYRY) (BAYZF) announced on Thursday that the U.S. Food and Drug Administration has granted priority review for its marketing application seeking a label expansion for its kidney disease ...

May 21 (Reuters) - Bayer (BAYGn.DE), opens new tab said on Thursday that the U.S. Food ⁠and Drug Administration had accepted its supplemental New Drug Application for finerenone and granted priority ...