USFDA

US Food and Drug Administration (US FDA) has accepted two Abbreviated New Drug Applications (ANDAs) of Sandoz for review, marking an important milestone in the company's efforts to introduce generic versions of tirzepatide in the United States.

The applications cover generic tirzepatide autoinjectors developed entirely through Sandoz's in-house research and development program. If approved, the products could become among the first generic alternatives to Mounjaro® and Zepbound®, expanding access to one of the fastest-growing classes of medicines used for diabetes and obesity.

Dr. Reddy's Laboratories Limited has informed the stock exchanges that the United States Food and Drug Administration (USFDA) has completed a Pre-License Inspection (PLI) at the company's biologics manufacturing facility located in Bachupally, Hyderabad.

According to the company's regulatory filing, the inspection was conducted from June 16 to June 25, 2026. At the conclusion of the inspection, the USFDA issued a Form 483 containing seven observations.

The U.S. Food and Drug Administration (FDA) has approved a new indication for Pfizer's IBRANCE (palbociclib), allowing its use in combination with trastuzumab, with or without pertuzumab, and endocrine therapy as maintenance treatment for adults with hormone receptor-positive (HR+), HER2-positive (HER2+) locally advanced or metastatic breast cancer following induction therapy. The approval marks a significant expansion for the widely used CDK4/6 inhibitor.

Biological E. Limited (BE) has achieved a major regulatory milestone with the U.S. Food and Drug Administration (FDA) granting approval for Dalbavancin for Injection, 500 mg per vial (single-dose vial). The product is the generic equivalent of DALVANCE® (dalbavancin) for injection, a widely used antibiotic for treating serious bacterial infections.

In a major advancement in the fight against antibiotic-resistant infections, the U.S. Food and Drug Administration (FDA) has approved Utebzi (tebipenem pivoxil hydrobromide), the first oral carbapenem antibiotic for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis. The approval provides patients and healthcare providers with a long-awaited oral alternative to intravenous carbapenem therapy.

In a significant step toward improving access to influenza treatment, the U.S. Food and Drug Administration (FDA) has approved the first generic version of baloxavir marboxil tablets, a single-dose antiviral medicine used for the treatment and prevention of influenza. The approval comes just before the start of the 2026-27 flu season and is expected to provide patients with a more affordable treatment option.

The U.S. Food and Drug Administration (FDA) has approved Xocova (ensitrelvir), developed by Japanese pharmaceutical company Shionogi & Co., for the prevention of COVID-19 following exposure to an infected individual. The approval makes Xocova the first and only oral antiviral therapy authorized in the United States for post-exposure prophylaxis of COVID-19.

AstraZeneca and Daiichi Sankyo have announced that the U.S. Food and Drug Administration (FDA) has approved DATROWAY (datopotamab deruxtecan-dlnk) for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. The approval makes DATROWAY the first TROP2-directed antibody-drug conjugate (ADC) approved in the United States for first-line treatment in this patient population.