FDA accepts for priority review a Genentech supplemental BLA for Tecentriq (atezolizumab) plus chemotherapy for first-line treatment of unresectable l...
FDA approves a PolyPid Ltd. IND for it to proceed with a Phase 3 clinical trial involving lead candidate D-Plex[100] for preventing post-cardiac surge...
Federal Register notice: FDA seeks comments on an information collection extension on a guidance for Medical Device User Fee Small Business Qualificat...
A Tufts Center for the Study of Drug Development analysis says the global biotech product development surge that started in the 1980s continues to gro...
FDA issues a draft guidance on considerations for using a metastasis-free survival endpoint in some prostate cancer drug trials.
FDA releases its latest batch of Warning Letters that include StemGenex Biologic Laboratories and U.S. Vascular.
FDA accepts for review a Shire supplemental NDA to expand the indication of Gattex (teduglutide [rDNA origin]) for injection to pediatric patients wit...
Federal Register notice: FDA submits to OMB a new information collection entitled Surveys and Interviews With Investigational New Drug (IND) Sponsors ...