FDA Plans for Expedited Licensure Approval of GSK’s Autism Drug
On Sept. 22, 2025, the U.S. Food and Drug Administration (FDA), in collaboration with the British pharmaceutical company GSK plc, announced plans to fast-track licensure of leucovorin calcium tablets. The drug, which GSK calls Wellcovorin, has long been used to treat anemia and counteract the effects of chemotherapy, The FDA will approve it for use […]
FDA Questions Safety of Giving Multiple Vaccines at Once
The U.S. Food and Drug Administration (FDA) is re-evaluating the long-standing federal vaccine use policy that allows multiple vaccines to be given during the same visit—particularly COVID-19, influenza and RSV shots. In a memo last month, Vinay Prasad, MD, MPH, director of the FDA’s Center for Biologics Evaluation and Research (CBER), wrote that the agency […]
DHHS Investigating Risks of Getting COVID Shots During Pregnancy
The U.S. Department of Health and Human Services (DHHS) is compiling case examples of reported harm related to receiving COVID-19 shots during pregnancy, according to sources cited by The Wall Street Journal in early September.1 Health officials plan to eventually publicly release the information they are compiling on the potential relationship between COVID shots and […]
European Commission Probes Sanofi for Possible Antitrust Violations Related to Flu Shots
French pharmaceutical company Sanofi said that European Commission (EC) officials carried out unannounced inspections at its premises in France and Germany as part of an investigation into its conduct in the seasonal influenza vaccine market.1 It is not clear whether the investigation has any impact beyond Europe, but Sanofi produces influenza vaccines for the U.S. […]
Nine States Unite in Northeast to Challenge CDC’s New Vaccine Use Recommendations
In response to recent changes made to vaccine use recommendations issued by the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC), nine northeastern states and New York City have formally established the Northeast Public Health Collaborative, a regional partnership they say is intended to improve coordination of […]
FDA to Release Report on Child Deaths After COVID Shots
On Sept. 4, 2025, the commissioner of the U.S. Food and Drug Administration (FDA), Marty Makary, MD, announced the agency will release a detailed report investigating deaths among children following receipt of COVID-19 shots.1 2 Dr. Makary stated that officials have begun carrying out an “intensive investigation” into reports submitted to the Vaccine Adverse Event […]