FDA publishes a guidance with its latest questions and answers on the implementation of regulations covering expanded access to investigational drugs ...
Tango Therapeutics reports that new data from its ongoing Phase 1-2 study of vopimetostat (TNG462) showed early signs of efficacy across multiple MTAP...
A ProPublica investigative report faults FDA for blocking information about foreign-made generic drugs that could help patients, doctors, and pharmaci...
The CDER Office of New Drugs publishes a MAPP on the regulatory basis for refusing to file an NDA, sNDA, BLA, or sBLA.
FDA publishes the checklists used by CDER reviewers to determine if an NDA or BLA can be accepted for filing.
Alector discontinues development of latozinemab for treating a rare genetic form of frontotemporal dementia after a Phase 3 trial missed its primary e...
FDA warns Chinas Foshan Yiying Hygiene Products Co. about CGMP issues in its production of over-the-counter drugs.
FDA warns Chinas Dongguan Rainbow Tech Electronic & Plastics Co. about Quality System Regulation violations in its manufacturing of manual emergency v...
