USFDA

The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets for the treatment of dermatomyositis in adults. For decades, dermatomyositis patients have had limited treatment options to manage their symptoms. The approval of Lisraya offers patients an important new alternative by providing an effective oral treatment option.

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.

The U.S. Food and Drug Administration (FDA) has approved Pasatru (garetosmab-grts) as a treatment for adults with fibrodysplasia ossificans progressiva (FOP), an extremely rare genetic disorder in which muscles, tendons and ligaments can gradually turn into bone. The approval makes Pasatru the second FDA-approved treatment for FOP, providing another therapeutic option for people affected by this debilitating condition.

Dr. Reddy’s Laboratories has received approval from the U.S. Food and Drug Administration (FDA) for its rituximab biosimilar, a biosimilar version of Rituxan® (rituximab), marking another significant milestone in the company's expanding global biosimilars business.

The approval enhances Dr. Reddy’s biologics portfolio and reinforces its presence in the highly regulated U.S. pharmaceutical market. The biosimilar was developed, manufactured, and submitted for approval entirely by Dr. Reddy’s Laboratories.

The U.S. Food and Drug Administration (FDA) has issued an Untitled Letter to Viatris Specialty LLC, stating that a direct-to-consumer (DTC) promotional video for TOBI® PODHALER® (tobramycin inhalation powder) contains false or misleading claims regarding the product's use. According to the FDA, the promotional material misbrands the drug under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The U.S. Food and Drug Administration (FDA) has approved Tylenol with Naproxen, the first nonprescription fixed-dose combination of acetaminophen and naproxen sodium for up to 12 hours of pain relief. The approval introduces a new over-the-counter (OTC) option for consumers seeking long-lasting, dual-action pain management without a prescription.

The U.S. Food and Drug Administration (US FDA) has issued a Warning Letter to Almon Healthcare Private Limited, Ahmedabad, Gujarat, after identifying significant violations of Current Good Manufacturing Practice (CGMP) regulations at its active pharmaceutical ingredient (API) manufacturing facility during an inspection conducted from February 9–13, 2026. The warning letter was issued on July 13, 2026.