BioPharma Dive July 3, 2024
By the end of September, the agency is set to make high-profile decisions on two novel psychiatric medicines, as well on drugs from Gilead and Ascendis.
Two of last year’s largest biotechnology company acquisitions centered on a new type of treatment for schizophrenia. By the end of September, the first of those therapies could win Food and Drug Administration approval, a decision that would highlight the new attention being paid to psychiatric drugs.
Other novel psychiatric treatments are working their way through testing, too, including psychedelics like MDMA and psilocybin. The FDA has a tough decision to make on that front, as a panel of its advisers recently panned the use of MDMA-assisted psychotherapy for post-traumatic stress disorder.
...