A RealClear Health column urges FDA not to overcorrect as it reconsiders its approach to investigational rare disease therapies.
Gilead petitions FDA to rescind its acceptance for filing of two Zydus 505(b)(2) applications for drugs that Gilead says are duplicates of its Descovy...
FDA clears a Neptune Medical 510(k) for its Triton 1 System, a robotic system for next-generation flexible endoscopy.
Sen. Elizabeth Warren says she is continuing to push Trump officials to release the actual contracts that have been signed with drug companies that ar...
Sidley attorneys say regulated companies should expect heightened federal government oversight due to a recent information-sharing memorandum of under...
The Senate HELP Committee prepares to hold a confirmation hearing for FDA commissioner nominee Heidi Overton as soon as next week.
FDA approves new safety warnings for AbbVies Kybella (deoxycholic acid) after identifying serious adverse events when the fat-dissolving drug was inje...
FDA finalizes a guidance intended to facilitate development of blood collection, processing and storage systems that would allow U.S. blood establishm...
