FDA posts a two-item Form FDA-483 from an August inspection of Sumitomo Pharmas Suzuka, Japan, manufacturing facility.
An FDA payroll system error causes a paycheck delay for some FDA employees who are designated to continue working during the ongoing government shutdo...
FDA approves Bayers Lynkuet (elinzanetant) to treat moderate to severe vasomotor symptoms associated with menopause.
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 ...
