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

A research team from the University of Oklahoma has pioneered a method that could accelerate drug discovery and reduce ...

Vanda Pharma announces Bysanti NDA with US filing; US FDA decision expected in early 2026: Washington Tuesday, May 6, 2025, 18:00 Hrs [IST] Vanda Pharmaceuticals Inc. (Vanda) anno ...

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

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

U.S. pharmaceutical companies are increasingly licensing new drugs from China. Former FDA Commissioner Scott Gottlieb ...

Jeremy Walsh is now heading up artificial intelligence and information technology in a newly created position at the FDA.

If istaroxime is granted the new chemical entity designation from FDA, it could provide 7.5 years of U.S. exclusivity and additionally the istaroxime U.S. issued method of use patent protects until ...

Explore how LC-MS technologies are transforming forensic and clinical toxicology by enabling comprehensive compound detection ...

The Trump administration revealed in a court filing that it will continue the Biden administration’s defense of the FDA’s ...

With only about $1.6 billion in debt in December 2024 compared with $0.3 billion in cash and investments, Waters maintains a financially flexible balance sheet with net leverage around 1 time. Waters ...