The FDA has granted priority review to an NDA for taletrectinib in the treatment of advanced ROS1-positive non–small cell ...

Chimerix submitted a new drug application to the FDA seeking accelerated approval for dordaviprone to treat patients with ...

The agency recently sent a warning letter to the company's CEO, Valentina Milanova, noting that an inspection of the ...

The FDA is expected to decide on treatments for Parkinson disease, PTSD and NF1-associated plexiform neurofibromas, in addition to 2 new vaccines.

A new drug application seeking the accelerated approval of dordaviprone forrecurrent for H3K27M-mutant diffuse glioma ...

On December 20, 2024, the US Court of Appeals for the Federal Circuit released its opinion in Teva Branded Pharm. Prods. R&D, Inc. v. Amneal ...

Product approvals in regenerative medicine and rare diseases are among the highlights in our recap of recent FDA regulatory decisions.

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) under Priority Review for avutometinib, in combination with defactinib, for the treatment of adults with ...

FDA officials have set a review date of June 30, 2025, to review avutometinib in combination with defactinib to treat ...

The blood-brain barrier (BBB) is a major hurdle for the development of systemically delivered drugs targeting diseases of the central nervous system (CNS). Because of this barrier there is a huge ...

Shanghai MicuRx Pharmaceutical Co., Ltd. announced that MRX-5, its self-developed anti-infection drug.

Corcept Therapeutics Incorporated CORT recently announced the submission of a new drug application (NDA) to the FDA for its ...