Drug Approval | April 21, 2025
FDA approves Medtronic’s new Simplera Sync sensor for the MiniMed 780G system
The Simplera Sync is a disposable, all-in-one sensor that requires no fingersticks with SmartGuard
The Simplera Sync is a disposable, all-in-one sensor that requires no fingersticks with SmartGuard
Vote expands existing recommendation, which was for all adults aged 75 and older and high-risk adults aged 60 to 74
YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor, is used to treat several different types of ophthalmology conditions
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
Raichur site is the group’s largest API facility and part of a wider network of seven sites
Subcutaneous pembrolizumab administered every six weeks with a median injection time of two minutes, in combination with chemotherapy, shows consistent results across reported efficacy and safety endpoints compared to IV KEYTRUDA in combination with chemotherapy
Abbott's investigational Coronary Intravascular Lithotripsy (IVL) System offers a new potential treatment by using sound pressure waves to treat arterial calcium blockages
Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure
Apitoria Pharma’s API manufacturing facility classified as VAI by USFDA
Talicia is also approved and launched in the UAE and additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes
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