Krystal Biotech KRYS reported first-quarter 2025 earnings per share (EPS) of $1.20, which missed the Zacks Consensus Estimate ...

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

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

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

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

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 ...

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 ...

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

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 ...

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

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for milsaperidone (Bysanti™) for the treatment of acute ...

For five years, the clinical-stage pharmaceutical company has developed Enbumyst, a nasal spray intended to remove excess ...