The FDA granted priority review to a new drug application for sunvozertinib as an oral treatment for certain patients with ...

Agios Pharmaceuticals, Inc. (AGIO), on Wednesday, announced that its supplemental New Drug Application seeking approval for the ...

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

Solid Biosciences received clearance from the Food and Drug Administration for an investigational new drug application, the company said Tuesday.

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

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

Among the FDA’s pending decisions for this quarter are Vertex’s non-opioid pain drug and Sanofi’s RNA interference therapy ...

SGT-212 is the company's novel, AAV-based FA gene therapy candidate designed to deliver full-length frataxin via systemic intravenous (IV) infusion as well as direct intradentate nuclei (IDN) infusion ...

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

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

Between 30-50% of adults with hypertension have OSA, and this number increases to between 70-80% in adults with resistant hypertension. Additionally, untreated moderate-to-severe OSA increases the ...

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.