Recuresion Pharma (RXRX) stock and other AI-driven biotechs surge as FDA embraces computational models over animal testing ...

The U.S. Food and Drug Administration said on Thursday it plans to replace animal testing in the development of monoclonal ...

The FDA previously granted breakthrough therapy designation to ziftomenib for relapsed/refractory NPM1-mutant AML.

The FDA issued a complete response letter for the resubmission of the reproxalap new drug application for the treatment of ...

U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low ...

The company stated that the FDA noted at least one additional adequate and well controlled study to demonstrate a positive ...

ST-001, an intravenous nanoformulation of fenretinide, will be evaluated in a phase 1a/1b small cell lung cancer trial.

Ziftomenib has received Breakthrough Therapy, Fast Track, and Orphan Drug Designations. The FDA has a 60-day filing review period to determine whether the NDA is complete and accepted for review; Kura ...

FDA has cleared an investigational new drug (IND) application to study switchable chimeric antigen receptor T cell (sCAR-T) therapy (CLBR001 + SWI019) in patients with autoimmune conditions. Patient ...

The FDA announced a shift away from animal testing for drug approval, citing advanced alternatives like AI and organoids ...

Tenpoint Therapeutics announced the submission of a New Drug Application (NDA) to the FDA for Brimochol PF (carbachol/brimonidine tartrate), a novel fixed-dose combination eye drop therapy for ...