Verrica Pharmaceuticals says it is filing an NDA resubmission in the first quarter next year for VP-102 to treat molluscum contagiosum.
Federal Register notice: FDA sends to OMB an information collection extension entitled Postmarket Surveillance of Medical Devices 21 CFR Part 822.
Federal Register notice: FDA seeks comments on an information collection extension entitled Certification of Identity; Form FDA 3975 (OMB Control Numb...
BioMarin Pharmaceutical says FDA is requesting results from an upcoming three-year data analysis from the ongoing Phase 3 GENEr8-1 study on its resubm...
FDA commissioner Robert Califf tests positive for Covid-19 while traveling over the weekend on agency business.
FDA posts a final guidance entitled M10 Bioanalytical Method Validation and Study Sample Analysis.
FDA updates the Health Care Provider Fact Sheet for Eli Lillys Covid-19 antibody therapy bebtelovimab to highlight expected reduced activity against c...
