Federal Register notice: FDA makes available a final guidance entitled Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Ph...
Federal Register notice: FDA posts a final guidance entitled M10 Bioanalytical Method Validation and Study Sample Analysis.
A Phase 3 trial of GSKs accelerated-approved Blenrep (belantamab mafodotin) in patients with relapsed or refractory multiple myeloma fails to meet its...
FDA slaps a clinical hold on a Verve Therapeutics IND for its VERVE-101 in patients with heterozygous familial hypercholesterolemia.
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...
