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

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

A new drug application seeking the accelerated approval of dordaviprone forrecurrent for H3K27M-mutant diffuse glioma treatment was submitted to the FDA.

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

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

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

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 ...

Verastem (NASDAQ:VSTM) said the FDA has accepted its New Drug Application for accelerated approval of its drugs avutometinib ...

Glaukos submitted an NDA for Epioxa, a novel corneal cross-linking therapy for keratoconus, to the US FDA. Epioxa's Phase 3 ...

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 ...

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 ...