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 ...

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

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 ...

The nonprofit Physicians Committee for Responsible Medicine, which promotes the use of human-relevant test methods to replace ...

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 ...

EVM14, an mRNA cancer vaccine, received FDA clearance for investigational new drug application, advancing Everest's mRNA technology to global clinical trials. Preclinical studies showed EVM14 induces ...

To achieve these ends, the FDA will use computer modeling and artificial intelligence (AI) to predict a drug’s behavior and ...

The U.S. Supreme Court on Wednesday largely backed the U.S. Food and Drug Administration's refusal to let two e-cigarette ...

This blog delves into the rise of rare disease drug approvals and the critical importance of regulatory guidance in shaping ...