Biotech | April 03, 2022
USFDA approves Yescarta as first CAR T-cell therapy for Lymphoma
Yescarta is First CAR T-cell therapy to receive NCCN treatment guideline category 1 recommendation --
Yescarta is First CAR T-cell therapy to receive NCCN treatment guideline category 1 recommendation --
No new studies have been requested
The valve has a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve
Approval is based on results of a multicenter, randomized, open-labeled and controlled IDE clinical study that demonstrated the superiority of Agili-C™ implant to the current surgical standard of care, debridement and microfracture in the knee joint
The companies are now preparing to initiate a Phase 1 trial to assess the safety and immunogenicity of BLB-201 in healthy volunteers
50 µg dose approved for all adults over 50 years of age and immunocompromised adults over 18 years of age
U.S. NIAID-sponsored trial will evaluate heterologous booster regimens, including NVX-CoV2373, after primary series with current USFDA approved or emergency use authorized-vaccines
Cabenuva was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen's decades-long commitment to combatting HIV
Titan 2 pivotal study to evaluate implantable tibial neuromodulation (TNM) device to help expand patient access to advanced therapy
The FDA decision is primarily informed by the positive results of a proof-of-concept, Phase 2a study evaluating the safety, immunogenicity, and efficacy of a single dose of 120µg RSVpreF in a human viral challenge model in healthy adults 18 to 50 years of age
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