Federal Register notice: FDA posts an updated listing of Emergency Use Authorizations for molecular diagnostic and antigen tests for Covid-19.
Federal Register notice: FDA sends to OMB an information collection extension entitled Record Retention Requirements for the Soy Protein and Risk of C...
FDA clears a Soundbite 510(k) for the SoundBite Crossing System Peripheral with an 0.014 Active Wire for treating peripheral artery disease.
Eli Lilly and and Incyte plan to file a supplemental NDA for baricitinib in alopecia areata after reporting positive data from a second Phase 3 trial.
FDA grants Lexeo Therapeutics a fast track designation for LX1001, an adeno-associated virus mediated gene therapy for treating apolipoprotein E4-asso...
FDA says BD is recalling 30 lots of its ChloraPrep 26 mL applicator due to a defective applicator.
FDA grants accelerated approval to GlaxoSmithKlines Jemperli to treat some endometrial cancers in patients with a specific biomarker determined by an ...
FDA grants 510(k) clearance to the Orthofix Forza titanium spacer system.