Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include ...

The FDA recently unveiled a new national priority voucher program that would seek to trade faster drug approvals for lower ...

On April 22, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) announced a plan to phase ...

The U.S. Food & Drug Administration (FDA) has approved certain GLP-1 drugs for commercialization and use, including liraglutide ...

The FDA has accepted for priority review a new supplemental biologics license application for Winrevair to treat adults with advanced pulmonary arterial hypertension, according to a press release ...

U.S. FDA Accepts New Drug Application for Merck’s Doravirine/Islatravir, an Investigational, Once-Daily, Oral, Two-Drug Regimen for Treatment of Adults with Virologically Suppressed HIV-1 Infection ...

U.S. FDA Accepts New Drug Application for Merck’s DOR/ISL Once-Daily Two-Drug Regimen for Treatment of Adults with Virologically Suppressed HIV-1.

Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product.

Connect Biopharma's collaborator Simcere has submitted a New Drug Application for rademikibart to treat atopic dermatitis in China.

Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in adults with schizophrenia compared to placebo CAPLYTA® is FDA approved to treat ...