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

Corcept Therapeutics Incorporated CORT recently announced the submission of a new drug application (NDA) to the FDA for its ...

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

had accepted the company’s New Drug Application (NDA) for TNX-102 SL, a 5.6 mg non-opioid analgesic for managing fibromyalgia, a chronic pain condition affecting over 10 million adults in the U ...

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 ...

Loteprednol Etabonate Ophthalmic Gel, 0.38% (RLD Lotemax SM) had an estimated annual sale of USD 36 million in the U.S.

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

Corcept Therapeutics submitted a new drug application to the Food and Drug Administration for its treatment of hypercortisolism, or Cushing's syndrome, a hormonal disorder that occurs when the body ...

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

has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for its proprietary, selective cortisol modulator, relacorilant, to treat patients with endogenous hypercortisolism ...

today confirms that the Company has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking accelerated approval for dordaviprone as a treatment for ...