pharmaceutical-regulation
5 stories related to this topic, newest first.
StatActing Director of FDA Drug Center Tracy Beth Høeg Leaves Agency
Tracy Beth Høeg, acting director of the Food and Drug Administration’s Center for Drug Evaluation and Research, is departing the agency. The departure comes days after Commissioner Marty Makary submitted his resignation. Michael Davis, the center’s current deputy director, will a…
thebalitimes.comFDA Rejects Replimune Melanoma Treatment RP1
The Food and Drug Administration declined to approve RP1, a genetically engineered treatment for melanoma developed by Replimune. One-third of participants in a 140-patient clinical trial saw their tumors shrink or disappear. The agency cited the lack of a control arm comparing t…
Substrate placeholder — needs reviewTakeda Pharmaceuticals Agrees to Pay 13.6 Million to Resolve False Claims Allegations
Takeda Pharmaceuticals U.S.A. Inc. will pay $13,670,921 to settle allegations that it paid kickbacks to physicians to induce prescriptions of its antidepressant Trintellix to Medicare and other federal health care programs. The settlement removes the company from further liabilit…
manilatimes.netMade-in-China Agrees to Stop Selling GLP-1 Compounds in U.S., Pays $30,000 Penalty to Connecticut
The international online platform agreed to halt all sales of GLP-1 medications to U.S. customers and pay a suspended $300,000 penalty. Connecticut Attorney General William Tong said the drugs contained impurities and inconsistent active ingredients with no generic versions legal…
Adrian McArdle, M.B, B.Ch., Kshemendra Senarath-Yapa, M.B.B.Chir., Graham G. Walmsley, B.S., Michael Hu, M.D., M.P.H., David A. Atashroo, M.D.,Ruth Tevlin, M.B., B.Ch.,Elizabeth Zielins, M.D.,Geoffrey C. Gurtner, M.D., Derrick C. Wan, M.D., and Michael T. Longaker, M.D., F.A.C.S. / Wikimedia (CC BY-SA 4.0)Nkarta Receives Approval for Outpatient Dosing in Lupus Nephritis Trial
Nkarta announced that regulators have approved a protocol change allowing outpatient dosing of its NKX019 therapy in lupus nephritis trials, reducing patient monitoring time to two hours. Following this update, Nkarta's stock price increased by approximately 13%.