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

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 ...

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

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

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 ...

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 ...

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

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.

Verastem (VSTM) said the FDA has accepted for priority review its application for accelerated approval of its ...

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

Following news that the U.S. Food and Drug Administration approved its New Drug Application for avutometinib ... action deadline of June 30, 2025, the FDA granted Priority Review, Verastem stated ...