Pharma News

Alembic Pharmaceuticals Limited has announced that it has received tentative approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Binimetinib Tablets, 45 mg. The company had earlier secured tentative approval for the 15 mg strength of the same drug.

The approved generic product is therapeutically equivalent to Mektovi Tablets, 15 mg, marketed by Array BioPharma. Binimetinib is a kinase inhibitor used in combination with encorafenib for the treatment of patients with specific forms of advanced cancer.

Aurobindo Pharma has successfully moved one step closer to completing its strategic acquisition of U.S.-based generic drug manufacturer Lannett Company after the U.S. Federal Trade Commission (FTC) approved the transaction subject to certain divestiture conditions.

The FTC announced that Aurobindo will divest four generic pharmaceutical products to Quagen Pharmaceuticals as part of a consent agreement designed to preserve competition in the U.S. generic medicines market. With this requirement in place, the proposed acquisition of Lannett can move forward toward completion.

GSK has announced an agreement to acquire Nuvalent, a clinical-stage biotechnology company focused on precision cancer therapies, in a transaction valued at approximately 10.6 billion USD. The deal significantly strengthens GSK's oncology pipeline and expands its presence in the rapidly growing lung cancer treatment market.

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).