The FDA has accepted for filing and priority review Sentynl Therapeutics’ CUTX-101 NDA for the treatment of Menkes disease.

The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for CUTX-101 (Copper Histidinate) for priority review, with a target action date set for June 30 ...

Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) letter to FDA Commissioner highlights faulty gastroparesis NDA review. As ...

Chimerix (NASDAQ: CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, announced today that Dr ...

SpringWorks has shown strong revenue growth with OGSIVEO, achieving a 23% increase from Q2 of 2024 to Q3 of 2024. See why I ...

Fortress Biotech, Inc. (NASDAQ:FBIO), a biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has extended the target action date for the New Drug Application ...

A Tasmanian theatre company says it is "deeply concerned" by allegations of misconduct involving Launceston councillor and ...

“The NDA submission for Epioxa represents an important ... “We look forward to working closely with the FDA in their pending review process and continue to believe Epioxa, which is designed ...

For branded drugmakers, the development of a pharmaceutical product approved by the Food and Drug Administration (FDA) all ...

On the basis of these findings, VSTM has pursued approval through a rolling NDA, completed in Q4 2024 ... assuming the review process goes smoothly. The market values this news and the entire ...