Articles related to FDA

A Phase 2 trial of luvesilocin reported rapid reductions in postpartum depression symptoms, with most treated participants reaching remission within seven days. The investigational psychedelic has received FDA Breakthrough Therapy designation, but Phase 3 confirmation remains pending.

The FDA expanded approval of the CRISPR-based gene therapy Casgevy to include patients as young as 2 years with sickle cell disease or transfusion-dependent beta thalassemia. The decision was supported by pediatric phase 3 data demonstrating sustained reductions in disease burden.

The FDA approved enlicitide, the first oral PCSK9 inhibitor, after phase 3 studies demonstrated substantial LDL-C reductions in patients requiring additional lipid lowering. Cardiovascular outcomes data remain pending.

The FDA classified the nationwide recall of more than 2.5 million bottles of Lupin’s prednisolone acetate ophthalmic suspension as a Class II recall after reports of a foreign substance in affected products.

The FDA has begun reviewing generic tirzepatide applications as global competition accelerates, despite US patent protections limiting near-term availability.

The FDA approved cefepime-zidebactam (Zaynich) for complicated UTI and pyelonephritis caused by susceptible gram-negative organisms. Approval followed phase 3 trial data showing higher rates of symptom and microbiologic resolution compared with meropenem in hospitalized adults.