After decades of development and trials, Medtronic has secured U.S. Food and Drug Administration approval for adaptive ...

Surgifort is the first FDA-approved human milk-based fortifier specifically designed for term infants recovering from ...

The FDA has approved the BLA for Ospomyv™ and Xbryk™, biosimilars to Prolia (denosumab) and Xgeva (denosumab), respectively.

Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President: Toichi Takino; “Ono”) announced that the U.S. Food and Drug Administration (FDA) ...

FDA approves vimseltinib for tenosynovial giant cell tumor and a triplet for R/R LBCL, plus the latest from ASCO GU 2025.

U.S. FDA Grants Full Approval of Deciphera’s ROMVIMZA™ (vimseltinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumor (TGCT) In the MOTION Phase 3 study, ROMVIMZA met primary ...

The primary endpoint, percent change from baseline in lumbar spine bone mineral density at week 12, was achieved in both full analysis ... “The FDA approval of Ospomyv and Xbryk marks a key ...

Less than two months after an accelerated approval from the FDA, a drug combination featuring Pfizer’s Braftovi has turned in positive trial results that could set it up for a full approval.

Ezra, the healthcare AI startup revolutionizing early cancer detection through full-body MRI screening, today announced new 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its ...

“The FDA approval of OSPOMYV and XBRYK marks a key step in improving ... do not include all the information needed to use OSPOMYV safely and effectively. See full prescribing information for OSPOMYV ...

[1] On Dec. 17, 2024, the FDA rejected full approval of the only currently available drug that reverses the anticoagulant effect of blood thinners, due to safety concerns pursuant to a complete ...