Industry 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 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.

The Advanced Research Projects Agency for Health (ARPA-H) has selected five research teams to develop new technologies aimed at making individualized, RNA-based genetic medicines faster and more accessible.

The initiative is part of ARPA-H’s Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program, which could receive up to 125 million USD in research and development funding. The program seeks to establish an automated, distributed manufacturing network capable of producing genetic medicines on demand and closer to the point of care.

Novartis has announced positive topline results from the Phase III REMODEL-1 and REMODEL-2 trials evaluating remibrutinib, an oral Bruton’s tyrosine kinase (BTK) inhibitor, in adults with relapsing multiple sclerosis (RMS).

The investigational therapy met the primary endpoint in both trials, demonstrating a statistically significant reduction in annualized relapse rate (ARR) compared with teriflunomide. The studies also reported favorable results across key secondary endpoints, including measures of inflammatory brain lesions seen on MRI.

Zydus Lifesciences has announced positive topline results from its global EVIDENCES-X™ Phase II(b) clinical trial evaluating Saroglitazar Magnesium in patients with Metabolic dysfunction-Associated Steatohepatitis (MASH) and fibrosis. The company said the study successfully achieved its primary endpoint, marking an important milestone in its ongoing MASH development programme.

The Trump administration has announced agreements with nine additional pharmaceutical manufacturers aimed at reducing prescription drug prices in the United States under its Most-Favored-Nation (MFN) pricing initiative.

The latest agreements bring the total number of pharmaceutical manufacturers participating in the administration's MFN arrangements to 26 companies, covering approximately 89% of the branded drug market, according to a White House fact sheet released on August 31.

A routine inspection by the United States Food and Drug Administration (US FDA) at Lannett Company LLC, a wholly owned step-down subsidiary of Aurobindo Pharma USA, Inc., has concluded with four observations.

The inspection was conducted at Lannett Company’s manufacturing facility in Seymour, Indiana, USA, from August 17 to August 21, 2026. According to the company’s regulatory filing, the inspection was carried out as part of the US FDA’s routine inspection process.