Morningstar11d
U.S. FDA Grants Full Approval of Deciphera’s ROMVIMZA™ (vimseltinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumor (TGCT)
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 ...
rheumatologyadvisor18h
FDA Approves Denosumab Biosimilars Ospomyv and Xbryk
The FDA has approved the BLA for Ospomyv™ and Xbryk™, biosimilars to Prolia (denosumab) and Xgeva (denosumab), respectively.
Pharm Exec13h
FDA Approves Prolacta Bioscience’s Surgifort for Infants Recovering from Gastroschisis Surgery
Surgifort is the first FDA-approved human milk-based fortifier specifically designed for term infants recovering from ...
In Parkinson’s fight, Medtronic’s first-in-the-world adaptive therapy feature wins FDA approval
After decades of development and trials, Medtronic has secured U.S. Food and Drug Administration approval for adaptive ...
WSLS 107d
WATCH: FDA approves new method to screen for cervical cancer
Pap smears are a regular part of health care for those at risk of cervical cancer, but for many patients, the test can be uncomfortable or embarrassing.
Targeted Oncology2d
The Targeted Pulse: Hot Off-The-Press Approvals and What to View from ASCO GU 2025
FDA approves vimseltinib for tenosynovial giant cell tumor and a triplet for R/R LBCL, plus the latest from ASCO GU 2025.
BioPharma Dive7d
GSK’s 5-in-1 meningococcal shot wins FDA approval
Penmenvy, which protects against five common types of disease-causing bacteria, is cleared for use in people aged 10 through ...
Business Wire10d
FDA Approves Samsung Bioepis’ OSPOMYV™, XBRYK™ (denosumab-dssb), a Biosimilar to Prolia and Xgeva
“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 ...
Monthly Prescribing Reference8d
FDA Approves Denosumab Biosimilars Ospomyv and Xbryk
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 ...