FDA grants Heidelberg Pharma a fast track designation for HDP-101 (pamlectabart tismanitin), the companys lead antibody drug conjugates candidate for ...
Ventyx Biosciences reveals positive Phase 2 data for its oral NLRP3 inhibitor VTX3232 in patients with obesity and cardiovascular risk factors.
FDA approves a GSK BLA for Blenrep (belantamab mafodotin-blmf) in combination with bortezomib (Velcade) and dexamethasone for treating adult patients ...
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.
