The Office of the Inspector General at the Department of Health and Human Services raised concerns on Wednesday regarding what it characterized as lapses in the FDA’s judgement in granting accelerated approval to certain medications. In a 32-page report, the Office of...
– PRGN-2012 has the potential to be the first FDA-approved therapeutic for the treatment of adults with RRP, a rare and devastating chronic disease for which the current standard-of-care is repeated surgeries –– PRGN-2012 received Breakthrough Therapy Designation from...
– GEMTESA® is the first and only beta-3 agonist approved for the treatment of men with OAB symptoms who are receiving pharmacological therapy for BPH – MARLBOROUGH, Mass., Dec. 23, 2024 /PRNewswire/ — Sumitomo Pharma America, Inc. (SMPA) announced today that the...
SILVER SPRING, Md., Dec. 20, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved Zepbound (tirzepatide) for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity, to be used in combination with a...
VANCOUVER, BC, Dec. 20, 2024 /PRNewswire/ – The International Society for Cell & Gene Therapy (ISCT) celebrates the US Food and Drug Administration’s (FDA) landmark decision to approve Mesoblast Limited’s allogenic, bone marrow-derived...
