[ 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]
FDA accepts for priority review an Astellas supplemental BLA for Padcev (enfortumab vedotin-ejfv) in combination with Mercks Keytr...[ Price : $8.95]
FDA awards a fast track designation to Myosin Therapeutics and its investigational drug MT-125 for treating brain cancer.[ Price : $8.95]
Alector discontinues development of latozinemab for treating a rare genetic form of frontotemporal dementia after a Phase 3 trial ...