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 ...

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

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 ...

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.

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.

The FDA has accepted a New Drug Application (NDA) for Karuna Therapeutics, Inc’s KarXT (xanomeline-trospium) treatment for schizophrenia in adult patients. The novel muscarinic antipsychotic is ...

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 ...

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 ...

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 ...