Pharma News

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.

AstraZeneca Pharma India has announced that the Central Drugs Standard Control Organisation (CDSCO) has approved an additional indication for Trastuzumab Deruxtecan (Enhertu) 100 mg/5 mL, allowing its use in combination with pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer. The approval covers patients whose tumors are classified as HER2-positive through IHC 3+ or ISH+ testing.

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.

In a significant milestone for pediatric oncology research, Indian researchers have established one of the country's largest childhood cancer survivorship cohorts, providing new insights into the long-term outcomes of children who have successfully completed cancer treatment.

Eisai has announced a significant investment in its manufacturing facility in Hatfield, United Kingdom, aimed at expanding its capabilities for medicines that require specialized cold-chain storage and transportation. The project is being supported by the UK Government through the Life Sciences Innovative Manufacturing Fund (LSIMF).

In a major step toward strengthening international regulatory cooperation, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA) have announced a new liaison programme designed to deepen collaboration between the two agencies. The initiative was unveiled during the DIA Global Annual Meeting in Philadelphia by MHRA Chief Executive Lawrence Tallon and FDA Deputy Commissioner Grace Graham.

Researchers at Mass General Brigham have developed a promising blood test that could help physicians identify head and neck cancer patients at higher risk of disease recurrence and poorer survival outcomes, potentially enabling more personalized treatment strategies and follow-up care.

Merck has announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab), as well as the newly approved subcutaneous formulation KEYTRUDA QLEx™, in combination with WELIREG® (belzutifan) for the adjuvant treatment of certain patients with renal cell carcinoma (RCC), the most common form of kidney cancer.