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 ...
rheumatologyadvisor13h
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 Exec8h
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 ...
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.
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 ...
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.
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 ...
Business Insider13d
UPDATE: SpringWorks Therapeutics Announces FDA Approval of GOMEKLI™ (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN
– GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN – – Approval based on positive data from Phase 2b ReNeu trial, which showed GOMEKLI treatment resulted in ...
Healio11d
FDA approves two hyaluronic acid fillers for nasolabial folds
The FDA has approved Evolysse Form and Evolysse Smooth injectable hyaluronic acid gels, two dermal fillers from Evolus, the ...
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 ...