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 ...

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

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 ...

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 ...

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

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 ...

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

President Donald Trump on Monday signed an executive order to incentivize drug manufacturing in the U.S., streamlining the ...

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