The U.S. Supreme Court grants FDA a temporary win by ordering a stay of a lower courts order to restrict the distribution of the abortion drug mifepri...
CDERs Office of Prescription Drug Promotion discusses a survey to better understand quantitative claims in direct-to-consumer prescription drug advert...
Applied Therapeutics says it will request a pre-NDA meeting with FDA on govorestat (AT-007) and its use in treating patients with galactosemia.
Federal Register notice: FDA announces that an emergency use authorization was granted 3/24 to BioSynchronicity Corp. for its C-Sync Covid-19 Antigen ...
FDA grants Lantheus Holdings and Point Biopharma Global a fast track designation for 177Lu-PNT2002 for treating metastatic castration resistant prosta...
After a delay caused by an FDA 2021 inspection and Warning Letter, the agency approves Medtronics MiniMed 780G insulin pump.
bluebird bio files for priority review a BLA for lovotibeglogene autotemcel (lovo-cel), a gene therapy for patients with sickle cell disease.
Generic drug lobbying arm says FDAs draft guidance entitled Product-Specific Guidance (PSG) Meetings Between FDA and ANDA Applicants Under GDUFA does ...
