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...
FDA issues a revised final guidance entitled Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling an...
Former Decision Diagnostics CEO Keith Berman (Westlake Village, CA) pleads guilty to securities fraud, wire fraud, and obstruction of an official proc...
