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 ...

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

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

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.

New Drug Application (NDA) is based on pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib that demonstrated durable responses and prolonged progression-free ...

A cancer specialist discussed the FDA's approval of Johnson & Johnson’s new drug, Talvey, an antibody-based therapy for adult patients with tough-to-treat blood cancers.

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.

President Trump's executive order aims to bring down drug prices and promote innovation, with Congress now needing to continue the reform.

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 patients with ...

Thunder Bay New safe-drug supply program in Thunder Bay, Ont., called 'a powerful step' forward Front-line workers, advocates react to Health Canada-funded pilot project to counter toxic street drugs ...

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 ...