FDA News

The FDA accepted the GSK BLA and granted priority review to what could be the first vaccine approved against RSV in adults aged ≥60 years, according to the company.

Another choice of booster may help increase follow-up vaccination among the 50% of US adults who have yet to get a first booster dose.

The FDA amended EUAs for omicron-adapted vaccines from both Pfizer and Moderna, authorizing the shots for children and adolescents.

Novel NMDA receptor antagonist approved for the treatment of major depressive disorder, first topical PDE4i approved for plaque psoriasis, and more.

The first-in-class dual incretin receptor agonist was granted fast track designation for investigation in adults with obesity or overweight with weight-related comorbidities.

Only 1 lot of each medication was affected by the mislabeling, according to generic repackaging and distribution services company Golden State Medical Supply.

Data from the pivotal phase 3 FIGARO-DKD cardiovascular outcomes trial with finerenone reaffirms the agent's dual cardiorenal risk reduction benefits in T2D-associated CKD.

Abelacimab is a dual-acting, fully human monoclonal antibody that selectively targets both factor XI and factor XIa with high affinity.

The FDA EUA amendments for updated booster vaccinations are based on clinical studies of the omicron BA.1 variant and preclinical data on the BA.4 and BA.5 variants.

The dextromethorphan HBr-bupropion HCI combination uses the first new oral MOA in 6 decades and is labeled to improve depressive symptoms starting at 1 week.