Merck & Co. has announced positive topline results from the Phase 3 ATLAS-UC induction-only study evaluating its investigational anti-TL1A monoclonal antibody tulisokibart in patients with moderately to severely active ulcerative colitis (UC).

According to the company, the study successfully achieved both its primary endpoint and key secondary endpoints, marking an important milestone in the development of a potential new treatment option for patients living with the chronic inflammatory bowel disease.

Ministry of Health and Family Welfare has prohibited the manufacture, sale and distribution of 16 Fixed Dose Combinations (FDCs) for human use across India with immediate effect.

The decision was taken under Section 26A of the Drugs and Cosmetics Act, 1940, following an extensive scientific review of drug combinations available in the Indian market. The move forms part of the government's ongoing efforts to ensure that only scientifically validated, safe and therapeutically justified medicines remain available to patients.

India's pharmaceutical sector has undergone a significant transformation over the past decade, driven by a combination of affordable healthcare initiatives, domestic manufacturing incentives, and innovation-focused policies. According to the Ministry of Chemicals and Fertilizers, the country has expanded access to low-cost medicines while simultaneously strengthening its position as a global pharmaceutical manufacturing hub.

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.