The FDA cleared the investigational new drug application for REC-4539, allowing for the start of a phase 1/2 trial in small ...

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

Discover outperforming stocks and invest smarter with Top Smart Score StocksFilter, analyze, and streamline your ...

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

Vanda (VNDA) has written a letter to FDA Commissioner Robert Califf asserting that the review of the market application for ...

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

Variant Bio, a small biotech company based in Seattle, is using genetic information from Indigenous people to develop drugs ...

Advancing Multiple Programs in Areas of Significant Unmet Medical Need Several Milestones Across Clinical Development Pipeline Expected in 2025 HOUSTON, Jan. 10, 2025 (GLOBE NEWSWIRE) -- , ...

Revidia Therapeutics Inc., a cardiac regenerative medicine company developing first-in-class small molecule drug therapies for heart injury, has announced that it has expanded its leadership team in ...

Catalyst Pharmaceuticals settles patent litigation with Teva, delaying generic Firdapse launch until 2035. Legal actions against other defendants remain ongoing.