[ Price : $8.95]
FDA publishes a guidance with its latest questions and answers on the implementation of regulations covering expanded access to in...[ Price : $8.95]
Tango Therapeutics reports that new data from its ongoing Phase 1-2 study of vopimetostat (TNG462) showed early signs of efficacy ...[ Price : $8.95]
A ProPublica investigative report faults FDA for blocking information about foreign-made generic drugs that could help patients, d...[ Price : $8.95]
The CDER Office of New Drugs publishes a MAPP on the regulatory basis for refusing to file an NDA, sNDA, BLA, or sBLA.[ Price : $8.95]
FDA publishes the checklists used by CDER reviewers to determine if an NDA or BLA can be accepted for filing.[ Price : $8.95]
Alector discontinues development of latozinemab for treating a rare genetic form of frontotemporal dementia after a Phase 3 trial ...[ Price : $8.95]
FDA warns Chinas Foshan Yiying Hygiene Products Co. about CGMP issues in its production of over-the-counter drugs.[ Price : $8.95]
FDA warns Chinas Dongguan Rainbow Tech Electronic & Plastics Co. about Quality System Regulation violations in its manufacturing o...