Tag Archives: approval

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With eyes on first allogeneic CAR-T approval, Precision touts 100% response in ‘small area of interest’ inhabitants – Endpoints News

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09
Jun

Pre­ci­sion Bio­Sciences has grand reg­u­la­to­ry am­bi­tions for its lead pro­gram: first al­lo­gene­ic CAR-T ther­a­py on the mar­ket. En route to meet­ing with the FDA lat­er this year on po­ten­tial reg­is­tra­tion strat­e­gy, the North Car­oli­na biotech is out with new in­ter­im Phase I/IIa clin­i­cal da­ta on its prized pos­ses­sion, dubbed PB­CAR0191. The an­ti-CD19 can­di­date is be­ing […]

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Healing

Idorsia’s insomnia drug will get U.S. FDA approval

Posted on by admin
10
Jan

Jan 10 (Reuters) – Swiss drugmaker Idorsia (IDIA.S) said on Monday it has received the U.S. Food and Drug Administration’s approval for its treatment for insomnia in adult patients. The drug, to be available under the brand name Quviviq, was approved in doses of 25 mg and 50 mg based on data from two late-stage […]

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