Allogene Therapeutics reports encouraging response rate data for its investigational ALLO-316 in advanced renal cell carcinoma, but the results also s...
Advocacy group Public Citizen criticizes FDA for dragging its feet in removing phenylephrine from the U.S. market.
Dizal Pharmaceutical submits an NDA for sunvozertinib for treating locally advanced or metastatic non-small cell lung cancer.
FDA extends its review of a Neurotech Pharmaceuticals BLA for NT-501 (revakinagene taroretcel) as a treatment for macular telangiectasia Type 2.
Four stakeholders respond to an FDA request for comments on guidance development and engaging with stakeholders on model-informed drug development.
Elekta Instrument AB recalls (Class 1) its Elekta Disposable Biopsy Needle Kit for the Leksell Stereotactic System due to microscopic debris found on ...
FDA watchers need patience as they wait to see who president-elect Donald Trump chooses to nominate as the next FDA commissioner.
Public Citizen preemptively criticizes expected 2025 legislation to authorize FDA to approve drugs for rare diseases based on substantial evidence rat...
