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...
Researchers say they are developing an adjuvant opioid use disorder vaccine.
FDA releases statistics for the first two quarters of FY 2021 on actions relating to section 505(j) ANDAs.
FDA releases a nine-item Form-483 less than 24 hours after it completed an inspection of Emergent BioSolutions Baltimore manufacturing plant that show...