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[Ad hoc announcement pursuant to Art. 53 LR] FDA approves Roche’s...

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Polivy combination is the first FDA-approved therapy in nearly 20 years for the first-line treatment of diffuse large B-cell lymphoma, an aggressive disease...

Ipsen receives new FDA PDUFA date for investigational palovarotene for the...

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  Ipsen receives new FDA PDUFA date for investigational palovarotene for the treatment of people with FOPPDUFA date has been set for 16 August...

FDA Accepts Eisai’s Filing of a Supplemental Biologics License Application and...

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Confirmatory Phase 3 Clarity AD data to be evaluated by FDA in determining whether to convert accelerated approval of LEQEMBI to a traditional...

Bioelectronic Medicine Company Boomerang Medical Earns FDA Breakthrough Device D… –...

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Boomerang Medical is currently enrolling a clinical trial studying a bioelectronic device for people living with Crohn's disease and ulcerative colitis, the two...

Stryker’s Q Guidance System for cranial applications receives FDA clearance –...

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Cranial Guidance Software offers surgeons robust imaging and guidance during cranial procedures Stryker SYK, one of the world's leading medical technology companies, today announced...

FDA Roundup: February 7, 2023 – Press Release

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SILVER SPRING, Md., Feb. 7, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from...

Accutar Biotechnology Announces FDA Clearance of IND Application for Phase 1...

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Accutar Biotechnology, Inc., a biotechnology company focusing on artificial intelligence (AI)-empowered drug discovery, today announced that the U.S. Food and Drug Administration (FDA)...

FDA Proposes Individual Risk Assessment for Blood Donations, While Continuing to…...

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SILVER SPRING, Md., Jan. 27, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration today announced it is proposing a change from time-based...

FDA approves Novartis Kymriah® CAR-T cell therapy for adult patients with...

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68% of patients receiving Kymriah in the ELARA trial experienced complete response, with an 86% overall response rate, along with a remarkable safety...

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