Researchers document the Medicare savings associated with skinny label biosimilars.
Republican Sen. Richard Burr says the lame-duck session of Congress will not consider reforming FDA oversight of dietary supplements.
Federal Register notice: FDA issues an order debarring Jennings Ryan Staley for five years from importing or offering for import any drug into the U.S...
FDA grants Caribou Biosciences a Regenerative Medicine Advanced Therapy designation for CB-010 and its use in treating relapsed or refractory large B ...
Federal Register notice: FDA announces a 1/24 Antimicrobial Drugs Advisory Committee meeting to vote on Cidara Therapeutics NDA for rezafungin.
Federal Register notice: FDA seeks nominations for voting members to serve on the Medical Devices Advisory Committee device panels.
FDA accepts for review a Sarepta Therapeutics BLA that is seeking accelerated approval for SRP-9001 (delandistrogene moxeparvovec) for treating ambula...
FDA clears a NeuroLogica 510(k) for its BodyTom 64 Point-of-Care Mobile Computed Tomography Scanner.
