Federal Register notice: CDER and CBER announce that support begins for version 2.0 of the Clinical Data Interchange Standards Consortium (CDISC) Stud...
Attorney Allyson Mullen sees the potential for chaos if FDA tries to implement its proposed rule on laboratory-developed tests without adequate resour...
More than half of all oncology drugs approved by FDA in the last decade had a postmarketing requirement to obtain better dosing (optimal dose) informa...
FDA approves a ReShape Lifesciences PMA supplement for the companys next-generation Lap-Band 2.0 FLEX, an implant indicated for weight reduction in pa...
MAPS Public Benefit Corp. files what it calls the first NDA submission for a psychedelic-assisted therapy, MDMA (midomafetamine capsules), for use in ...
Trump-associated America First Legal files a lawsuit against FDA and HHS for illegally concealing government records related to the suppression of hyd...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Peloton Therapeutics Welireg (belzutifan).
FDA accepts for review a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) as a daily treatment for heartburn associated with non-erosive gastroes...
