On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for ...

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

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

Significant advancements in lung cancer treatment were seen throughout 2024, from new drug approvals to promising clinical ...

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 ...

Nitroxoline has not been approved by the FDA, and its use is therefore considered investigational. FLA patients will receive ...

Fortress Biotech (FBIO) and its majority-owned subsidiary, Cyprium Therapeutics announced the acceptance for review of the New Drug Application ...

By the end of March, the regulator could clear a highly anticipated pain drug from Vertex and a heart drug that’s critical to Alnylam’s future.

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 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 ...