Tag: FDA
Moderna: asks the FDA for a 4th dose of the vaccine
(CercleFinance.com) – Moderna has announced that it has submitted an application to the US Food and Drug Administration (FDA) for a change to the Emergency Use Authorization (EUA) to allow…
AstraZeneca: FDA requests more data on Fasenra
(CercleFinance.com) – AstraZeneca announces that the U.S. Food and Drug Administration (FDA) has issued a Comprehensive Response Letter (CRL) regarding the Supplemental Biologics License Application (sBLA) for Fasenra (benralizumab) how…
Philips: the FDA validates a remote diagnostic tool
(CercleFinance.com) – Philips announced on Friday that the FDA has approved its ‘Collaboration Live’ remote diagnostics solution for use on various mobile platforms. Available on Epiq and Affiniti ultrasound systems,…
Mediantechnologies: Median wants its lung cancer screening software approved by the FDA
(BFM Bourse) – The Côte d’Azur company specializing in artificial intelligence applied to medical imaging has submitted a dossier to the American health agency to have its software/medical device iBiopsy…
Ose immuno: FDA Fast Track Designation for VEL-101
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OSE Immunotherapeutics is pleased to announce FDA Fast Track Designation for CD28 antagonist VEL-101/FR104, granted by Veloxis Pharmaceuticals, Inc., its partner in transplantation – 02/17/2022 18:00
Nantes, France – February 17, 2022, 6:00 p.m. – OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) announces that Veloxis Pharmaceuticals, Inc., a subsidiary of Asahi Kasei, has obtained “Fast Track”…
Sanofi: FDA approves Enjaymo to treat cold agglutinin disease
PARIS (Agefi-Dow Jones)–The pharmaceutical group Sanofi announced Friday evening that the Food and drug administration (FDA), the American health authority, had approved its drug Enjaymo, to reduce the use of…
OSE Immuno: FDA green light for Veloxis Pharmaceuticals
(CercleFinance.com) – OSE Immunotherapeutics announces that the United States Food & Drug Administration (FDA) has accepted the Investigational New Drug (IND) application formulated by Veloxis Pharmaceuticals for a clinical trial…
Roche: green light from the FDA in the USA for Vabysmo
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Roche/Genentech: FDA approves eye drug Faricimab
Zurich (awp) – Genentech, a US subsidiary of Roche, has obtained approval from the US health authority FDA for the eye drug Faricimab, which will be marketed under the name…
Roche: priority review granted by the FDA in SMA
(CercleFinance.com) – Roche announces that the United States FDA has granted priority review of a Supplemental New Drug Application for the use of Evrysdi (risdiplam) to treat presymptomatic babies under…
Gensight biologics: Taking the plunge with an FDA request
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