Medical Device | March 31, 2022
USFDA approves Edwards Mitris Resilia valve
The valve has a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve
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
Aquavit will officially unveil the Dermatox and Microtox programs at the Annual American Academy of Dermatology, the world's largest dermatology conference scheduled from March 25-29, 2022, in Boston, MA
Cabenuva was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen's decades-long commitment to combatting HIV
USFDA also approved complementary diagnostic imaging agent, Locametz, after radiolabeling with gallium-68 for the identification of PSMA-positive lesions
The product will be manufactured at Lupin’s facility in Goa, India
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
According to IQVIA sales data for the period ending January 2022, Vimpat tablets market achieved annual sales of approx. US $ 1.7 billion
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