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Generic drug lobbying arm says FDAs draft guidance entitled Product-Specific Guidance (PSG) Meetings Between FDA and ANDA Applicants Under GDUFA does ...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.
Avanos Medical recalls its Avanos Ballard Access Closed Suction System with Y-Manifold or Elbow Manifold after receiving complaints about cracked mani...
FDA extends by three months its review of a Daiichi Sankyo NDA resubmisson for quizartinib in combination with chemotherapy for treating adult patien...
CDER denies a 2021 citizen petition from Bausch Health that urged FDA not to approve any ANDA that cites Duobrii as the reference-listed drug unless t...
