FDA News

Your daily dose of clinical news you may have missed.

Teplizumab, an anti-CD3 monoclonal antibody, delayed the median onset of stage 3 T1D by approximately 2 years compared to placebo in a pivotal clinical trial.

A preliminary assessment from the FDA suggests certain naloxone products may be safely used without a prescription to prevent opioid overdose deaths.

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.