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 ...

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 ...

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

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 ...

The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug ...

Absci will use AMD’s $20 million investment to enhance its AI models. In parallel, the companies will collaborate to develop ...

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

The FDA is reviewing new vaccines for meningitis and chikungunya and therapies for Parkinson disease and PTSD.