By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often ...

The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency. | ...

"The FDA’s acceptance of our New Drug Application takes us another step closer to bringing relacorilant to patients with hypercortisolism," said Joseph Belanoff, M.D., Corcept’s Chief ...

Nature Medicine explores the latest translational and clinical research news, with a New Drug Application from Sage Therapeutics and Biogen for their GABA receptor agonist.

The FDA accepted a new drug application from Astellas for fezolinetant, a nonhormonal drug for treating moderate to severe menopause-related vasomotor symptoms, according to a company press release.

Alnylam Submits Supplemental New Drug Application (sNDA) ... we are a significant step closer to bringing vutrisiran to patients with ATTR amyloidosis with cardiomyopathy, ...

Potential Positives. Chimerix has submitted a New Drug Application (NDA) for dordaviprone, seeking accelerated approval from the FDA, which is a significant step towards bringing the treatment to ...

Gilead pharmaceutical company announced today (Tuesday, Feb. 18) that the U.S. Food and Drug Administration has accepted the company’s “new drug applications” for lencapavir, a twice-yearly ...

Avita has a new Drug Repository Program that will distribute donated unexpired prescription medications to qualifying patients at no cost.

Patients with stiff person syndrome are one step closer to having access to a new treatment. Kyverna Therapeutics’ new drug, KYV-101, has been designated by the U.S. Food and Drug Administration ...

Amneal Pharmaceuticals resubmitted a new drug application for its migraine treatment to the Food and Drug Administration, and additionally received approval for its diabetes and obesity treatment ...