FDA warns Alexandria, Egypt-based Pharmaplast about CGMP violations in its manufacturing of finished drugs.
In two suits, Florida says FDA is violating the Freedom of Information Act by not responding to the states request for information on its application ...
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.
