Pharma News

American Regent, Inc. has announced a voluntary nationwide recall of three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multiple-dose vials in the United States. The recall, announced on September 3, 2026, was initiated after complaints involving leaking and cracked vials raised concerns about the sterility of the affected products.

The U.S. Food and Drug Administration (FDA) has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in pediatric and adult patients, marking the first FDA-approved therapy for this rare and progressive neurological disorder.

Cigarette smoke and e-cigarette aerosol may have lasting effects on the body's immune system and blood-forming cells, according to a new study by researchers at the University of California, Irvine. The research found that exposure to cigarette smoke and e-cigarette vapor altered immune responses and affected hematopoiesis, the process through which blood cells are produced. The findings raise concerns about the potential long-term consequences of both conventional smoking and vaping on immune function and the hematopoietic system.

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Fresenius Medical Care AG & Co. KGaA, citing significant Current Good Manufacturing Practice (CGMP) violations at its Ogden, Utah manufacturing facility.

The Central Drugs Standard Control Organization (CDSCO) has cancelled three registration certificates issued to M/s Skintl Enterprises Pvt. Ltd., citing multiple violations related to the import, labelling and handling of cosmetic products. The cancellation order was issued by the Central Licensing Authority on 24 August 2026.

The U.S. Food and Drug Administration (FDA) has issued a detailed warning about the risks associated with unapproved and compounded GLP-1 drugs being used for weight loss, highlighting concerns related to product quality, dosing errors, counterfeit medicines and improper storage.

Gland Pharma Limited has announced the successful conclusion of a routine Good Manufacturing Practice (GMP) inspection conducted by the United States Food and Drug Administration (USFDA) at its facilities in Visakhapatnam.

The inspection was carried out at the company’s VSEZ Sterile Oncology Formulations Facility and API Facility in Visakhapatnam. The regulatory inspection commenced on August 24, 2026, and concluded on September 1, 2026.

A new study published in Acta Clinica Belgica has found that vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKIs) can produce substantial tumor shrinkage in patients with metastatic clear-cell renal cell carcinoma (ccRCC) involving the pancreas.