The latest headlines across every section, pulled from official and open-access sources.
The U.S. Food and Drug Administration today approved Otarmeni (lunsotogene parvec-cwha), the first-ever dual adeno-associated virus (AAV) vector-based gene therapy.
Public health resources can help protect individuals and their families this tick season
34 people across 13 states have gotten sick with the same strain of Salmonella
This report describes contact tracing following mpox exposures during commercial air travel.
This report describes flu vaccination coverage among nursing home residents and health care providers working in nursing homes.
CMS and FDA announce the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, a new pathway designed to expedite access to certain FDA-designated Class II and Class III Breakthrough Devices for people with Medicare.
This week, we explore new strategies for blood-pressure control after intracerebral hemorrhage, Covid-19 treatment in higher-risk patients, hormonal therapy for prostate cancer, and anesthesia for tracheal intubation. We review spinal epidural abscess and follow a case of progressive weakness and liver lesions. We examine advances in tRNA research, and Perspectives discuss the use AI in prescribing, pediatric drug research, the impact of pharmaceutical mergers, and the goals of care.
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. — SUN PHARMACEUTICAL INDUSTRIES INC · Class II · Ongoing
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. — Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Class II · Ongoing
Chemical contamination: Presence of benzene — Owen Biosciences Inc. · Class II · Ongoing
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. — Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Class II · Ongoing
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. — Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Class II · Ongoing
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. — Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Class II · Ongoing
Subpotent Drug — Island Kinetics, Inc. d.b.a. CoValence Laboratories · Class III · Ongoing
Lack of Assurance of Sterility — PAYLESS COMPOUNDERS, LLC · Class II · Ongoing
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit — Cipla USA, Inc. · Class II · Ongoing
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners. — Apotex Corp. · Class II · Ongoing
Lack of Assurance of Sterility — International Medication Systems Ltd. · Class II · Ongoing
Chemical contamination: Presence of benzene — Owen Biosciences Inc. · Class II · Ongoing
Subpotent Drug — Island Kinetics, Inc. d.b.a. CoValence Laboratories · Class III · Ongoing
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. — SUN PHARMACEUTICAL INDUSTRIES INC · Class II · Ongoing
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit — Cipla USA, Inc. · Class II · Ongoing
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. — Xiamen Kang Zhongyuan Biotechnology Co., Ltd. · Class II · Ongoing
Labelling: Illegible label — Nephron SC, LLC · Class II · Ongoing