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

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

Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, ...

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

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

New Jersey-based pharmaceutical company UCB has sued to protect its patents for a Parkinson’s drug after an India-based ...

Corcept Therapeutics (CORT) has submitted a new drug application to the FDA for its proprietary, selective cortisol modulator, relacorilant, to treat patients with endogenous hypercortisolism.

Shares of Verastem Oncology VSTM rallied 40.9% on Tuesday after it announced that the FDA has accepted the new drug ...

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

Chimerix, a biopharmaceutical company, announced it has submitted a New Drug Application (NDA) to the FDA for accelerated approval of dordaviprone as a treatment for recurrent H3 K27M-mutant ...

Corcept Therapeutics (CORT) has submitted a new drug application to the FDA for its proprietary, selective cortisol modulator, relacorilant, to ...

This NDA submission marks a pivotal moment for Chimerix in our mission to bring this potentially life-altering drug to patients diagnosed with recurrent H3 K27M-mutant diffuse glioma,” said Mike ...