An FDA advisory committee has recommended approval of Zevra Therapeutics' arimoclomol for the ultra-rare disorder Niemann-Pick disease, three years after the regulator rejected the drug.
Bayer has filed for approval in the US for elinzanetant as a non-hormonal treatment for menopausal symptoms such as hot flushes, with a rival therapy from Astellas in its sights.
Vertex Pharma has filed for FDA approval of its non-opioid pain drug suzetrigine, starting the clock ticking on a review that should be completed early next year.
The EMA's human medicines committee has recommended against approval of Eisai and Biogen's Alzheimer's disease therapy Leqembi, after regulators in the US, China, and Japan gave a green lig
FDA reviewers were so frustrated by AstraZeneca's application for Imfinzi as a treatment before and after surgery for resectable non-small cell lung cancer (NSCLC) that they voted for a ret
Johnson & Johnson has filed for FDA approval of its antidepressant nasal spray Spravato, hoping to make it the first standalone treatment for adults with treatment-resistant depression