FDA

October 4, 2024 9:35 PM

Thermo Fisher’s plant making infant RSV drug breached FDA rules, documents show

One of the largest contract drug manufacturing plants in the U.S. owned by Thermo Fisher Scientific over the past 10 years has repeatedly breached rules meant to ensure drugs are free of contamination, FDA documents show, including twice this year. The most recent U.S. Food and Drug Administration inspection of Thermo Fisher's Greenville plant in May identified manufacturing issues for the respiratory syncytial virus drug Beyfortus, a preventive antibody therapy from AstraZeneca and Sanofi for ...

FDA asks COVID vaccine makers to target KP.2 strain, if feasible, for next shot

The U.S. health regulator has changed its strain recommendation for the 2024-25 COVID-19 vaccines, as it asked manufacturers to update the new shots to target the KP.2 variant, if feasible, instead of the JN.1 lineage it sought to target earlier. The Food and Drug Administration's change in recommendation, in an update dated Thursday, comes even as Moderna and Novavax makers of two of the three COVID vaccines submitted their applications to the agency for updating the fall 2024 season shots wit...