The FDA cleared the investigational new drug application of IDE849, a potential first-in-class DLL3-targeted antibody-drug ...

The FDA has accepted the new drug application for the antipsychotic Bysanti and set a goal date for February 21, 2026.

Viatris shares favorable Phase 3 data for contraceptive patch and pain drug, affirms 2025 sales, and raises adjusted EPS ...

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for milsaperidone (Bysanti™) for the treatment of acute ...

New Delhi: Through a recent notice, the Central Drugs Standard Control Organisation (CDSCO) has issued revised guidance ...

The investigational transdermal delivery system, known as Xulane Lo, is designed to deliver 150mcg of norelgestromin and 17.5mcg of ethinyl estradiol per day.

The product, available in 200 mg, 400 mg, 600 mg, and 800 mg strengths, is the generic equivalent of Sumitomo Pharma ...

Ahmedabad: Senores Pharmaceuticals Limited, through its wholly-owned subsidiary Senores Pharmaceuticals, Inc., USA, has ...

The FDA accepted Novo Nordisk's NDA for an oral formulation of Wegovy. The agency is expected to release its verdict on the ...

Qure advances its Huntington’s program toward accelerated approval as PTC Therapeutics reports strong Phase 2 results. Learn ...

Explore cutting-edge methods for detecting alcohol biomarkers and drugs of abuse using alternative sample matrices.

The FDA has communicated to Stealth BioTherapeutics that it would not meet elamipretide’s PDUFA target date for the treatment of Barth syndrome.