News

As gene therapy maker Sarepta Therapeutics tangles with FDA over its Duchenne treatment, patients and their families are ...
Under the leadership of the U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr. and the U.S.
But a recent move from the U.S. Food and Drug Administration and U.S. Department of Agriculture may end up giving the term ...
Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...
The two agencies announced a joint request for information to gather data to establish a federally recognized, uniform ...
GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...
From softwares to implants, here are 10 spine products earning FDA nods since May 15. 1. Accelus’ FlareHawk interbody fusion device was FDA-cleared for use in MRI scanning under certain conditions.
Verastem Oncology ( NASDAQ: VSTM) said that the U.S. FDA has granted fast track designation to its experimental drug ...
The US Food and Drug Administration appears poised to continue with a plan to ban prescription fluoride supplements at a time ...
Move over, artificial food colors, the FDA just approved gardenia (genipin) blue, a plant‑derived dye to shake up drinks and ...
It's shaping up to be a big year for Boehringer Ingelheim—at least if the FDA plays ball. | Boehringer Chief Medical Officer ...
The U.S. Food and Drug Administration has extended its review of GSK's blood cancer drug, Blenrep, as a combination treatment, the company said on Wednesday.