The Bagsvaerd, Denmark, company said that if the application is approved, Wegovy would become the first oral formulation of a ...

Lupin's approved tablets, indicated for the treatment of HIV-1 infection, are bioequivalent to Merck Sharp & Dohme LLC’s ...

Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity. This product ...

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

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

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

The U.S. Food and Drug Administration has accepted Novo Nordisk's marketing application for an oral version of its ...

THE new Food and Drug Administration (FDA) application procedures are expected to reduce the drug permit process by as much ...

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

On April 2, 2025, Cingulate completed its Pre-NDA meeting with the FDA to discuss the submission of an NDA for CTx-1301, its ...

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