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Generic drug lobbying arm says FDAs draft guidance entitled Product-Specific Guidance (PSG) Meetings Between FDA and ANDA Applicants Under GDUFA does ...
FDA places a partial clinical hold on a Foghorn Therapeutics clinical study of FHD-609 in synovial sarcoma and SMARCB1-deleted tumors after the compan...
FDA clears a Maxtec 510(k) for the MaxO2 ME+p, an oxygen monitor with integrated pressure monitoring intended for continuous patient monitoring.
