FDA grants a de novo marketing authorization for Paige AIs Paige Prostate software that is intended to assist pathologists in detecting areas that are...
FDA defers a review action on an Alvotech BLA for AVT02, the companys proposed biosimilar of AbbVies Humira (adalimumab) Humira, until manufacturing f...
Two Hyman, Phelps attorneys analyze the top 10 things they like in the FDA PUDFA 7 goals letter.
Researchers writing in the Annals of Internal Medicine say FDA must find ways to improve institutional memory of drug review decisions and use them as...
FDA and Health Canada announce a 10/8 regional public consultation on recent International Council for Harmonization activities and future topics, suc...
FDA says NDA and ANDA sponsors who submitted study data developed by Indias Panexcell Clinical Lab or Synchron Research Services must repeat the studi...
Johnson & Johnson reports new data showing increased protection against Covid-19 when a booster shot of its vaccine is administered.
FDA warns the Fibromyalgia Treatment Group it is selling unapproved new drugs.