FDA Flags Manufacturing Issues at Biologics Facility in India
The U.S. Food and Drug Administration (FDA) has flagged violations at a large manufacturing facility in India, which distributes biologics and drugs in the United States. The FDA issued a Form 483 with seven inspection observations following a recent review of Dr. Reddy’s Laboratories, a biologics manufacturing facility in Bachupally, Hyderabad, India. The agency has […]
First Trimester COVID-19 Shot Linked to Birth Defects in New Registry Study
A new registry-based cohort study out of Iran published in Sage Journals on June 15, 2026, has found a higher incidence of congenital anomalies, or birth defects, in babies born to women who received a COVID-19 shot within the first trimester of pregnancy compared with those who did not get vaccinated or were vaccinated after […]
FDA Leadership’s “Blind Spots” Lead to a Surge in Medical Device and Drug Recalls
Americans assume that when they pick up a prescription from their pharmacy, an FDA quality control professional has verified that the contents are manufactured to rigorous agency standards. Unfortunately, that assumption is becoming harder to defend. For decades, the FDA’s drug oversight model has depended on in-person inspections of the manufacturing practice and independent verification […]
OB-GYN Trade Group Breaks with CDC and Makes Own Maternal Vaccination Recommendations
The American College of Obstetricians & Gynecologists (ACOG) has split from the U.S. Centers for Disease Control and Prevention (CDC) for the first time ever, releasing its own 2026 recommended maternal vaccine schedule.1 2 The new schedule is endorsed by 13 medical societies and health organizations including the American Academy of Family Physicians (AAFP) and […]
Merck Settles Gardasil Vaccine Injury Lawsuit for $50 Million
Merck & Co has agreed to pay $50 million to settle more than 200 lawsuits brought against the drug giant by patients suffering from autoimmune disorders after receiving the Gardasil vaccine. According Merck, this settlement resolves all but one of the pending lawsuits filed against its HPV vaccine.1 Gardasil was fast-tracked to licensure by the […]
FDA Panel Backs mFlusiva mRNA Flu Shot for Elderly
Despite a number of significant limitations in the available safety and efficacy data for licensure review of Moderna, Inc.’s new mRNA influenza biologic mFlusiva, the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee ((VRBPAC) voted on June 18, 2026 to recommend fast-tracked licensure of the first mRNA product to target […]