Tag: FDA
[Ad hoc announcement pursuant to Art. 53 LR] FDA approves Roche’s...
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...
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...
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… –...
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 –...
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
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...
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…...
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...
68% of patients receiving Kymriah in the ELARA trial experienced complete response, with an 86% overall response rate, along with a remarkable safety...