The U.S. Food and Drug Administration on 21 July 2025 convened a two-hour public advisory meeting to review the benefits and risks of prescribing selective serotonin reuptake inhibitors during pregnancy. The discussion was led by surgeon and author Dr. Marty Makary, who opened the session by arguing that wider antidepressant use has failed to curb depression rates. Agency staff also cited studies suggesting serotonin may influence fetal heart, brain and gut development, and several speakers pointed to observational work that links prenatal SSRI exposure to a higher incidence of autism. Most of the invited experts have previously questioned the value of antidepressants and some market services such as paid “tapering” programs, a lineup that critics said skewed the debate. Psychiatric specialists monitoring the session called several of the presentations misleading and warned that overstating unproven harms could deter pregnant patients from treatment, even though untreated depression is a leading contributor to pregnancy-related deaths in the United States. No immediate regulatory action emerged from the meeting, but analysts said the tone could create headline risk for companies with large antidepressant franchises, including Eli Lilly. The FDA did not provide a timeline for any follow-up steps, leaving drugmakers and clinicians uncertain whether labeling changes or additional studies might be requested.
EU regulators backing Moderna Opens up more opportunities for company to expand in EU region $MRNA https://t.co/UK6ZOSpMLZ
$MRNA sentiment: Positive EU Regulators said to back Moderna vaccine
A panel of the European medicines regulator has recommended approving an eco-friendly version of AstraZeneca's inhaler for the treatment of a chronic lung condition, the drugmaker said on Friday. https://t.co/lhNHD9PQvs