FDA sends Sydnexis a complete response letter for SYD-101, a low-dose atropine eye-drop candidate intended to slow disease progression in children wit...
FDA grants Partner Therapeutics a breakthrough therapy designation for zenocutuzumab-zbco and its use in treating cholangiocarcinoma defined by NRG1 g...
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...
