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.

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 ...

Optimi Health Corp, a manufacturer of GMP-certified MDMA and psilocybin, has received its U.S. FDA Establishment Identifier ...

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 ...

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

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 ...

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 ...

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

As the adoption of biologics rises, demand for home healthcare grows, and conditions like diabetes and autoimmune disorders ...

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 ...