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 US Food and Drug Administration (FDA) has granted clearance to CureVac's investigational new drug application (IND) for ...

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

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

In Actavis Labs. FL, Inc. v. U.S.  (“Actavis”), a recent precedential decision, the Federal Circuit answered an important ...

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

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 ...

In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending ...

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

A second phase 1 trial plans to evaluate CER-1236, a novel chimeric antigen receptor therapy, for solid tumors.

Received positive feedback on New Drug Application submission via the 505(b)(2) pathway-Company leveraging existing human pharmacokinetic data ...

The FDA is requesting additional data demonstrating the effectiveness of reproxalap on treating ocular symptoms of dry eye. The Food and Drug Administration (FDA) has again issued a Complete ...