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

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

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 ...

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

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

Atara Biotherapeutics said a clinical hold on its new drug applications for its Ebvallo tabelecleucel program to treat Epstein-Barr virus by has been lifted by the Food and Drug Administration. The ...

Q1 2025 net product revenue for ZORYVE ® (roflumilast) was $63.8 million, a 196% increase compared to Q1 of 2024, and a 2% decrease compared to Q4 of 2024, due to typical first-quarter deductible ...

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

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 ...

Robert F. Kennedy Jr. is being sued by California, New York, Washington, Arizona, Colorado and other states over what they ...