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 ...

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

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

On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for ...

Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025Cyprium is eligible to receive royalties and up to $129 ...

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

By Karen Roman Oculis Holding AG (Nasdaq: OCS) said Phase 2 of its neuroprotective candidate OCS-05 met key endpoints of ...

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.

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

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 ...

FDA experts report changes in drug approvals, warnings, and indications for products for use by dermatologists and aesthetic medicine professionals.