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Martedì 19 Ottobre 2021
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FDA

Covid, mix di anticorpi per prevenirlo: AstraZeneca chiede ok Fda Usa

AstraZeneca ha presentato all'Agenzia americana del farmaco Fda la richiesta di autorizzazione all'uso di emergenza (Eua) per AZD7442, una combinazione di anticorpi monoclonali a lunga durata d'azione (Laab), per la profilassi di Covid-19 in forma sintomatica. "Se il via libera venisse concesso - sottolinea il gruppo farmaceutico anglo-svedese - AZD7442 sarebbe il primo Laab a ricevere un'Eua per la prevenzione di Covid-19".

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Occlutech granted important conditional FDA approval for PFO Study (OCCLUFLEX) in the U.S.

SCHAFFHAUSEN, Switzerland, Aug. 16, 2021 /PRNewswire/ -- Occlutech Holding AG ("Occlutech"), one of the world´s leading providers of minimally invasive structural heart disease devices, announces the conditional U.S. Food and Drug Administration ("FDA") approval of its Investigational Device Exemption ("IDE") application to conduct a pivotal study, OCCLUFLEX, comparing Patent Foramen Ovale ("PFO") closure by Occlutech's Flex II PFO Occluder to the standard of care for PFO occlusion in patients wi...

Inbiose applies for FDA GRAS approval of four new Human Milk Oligosaccharides

GHENT, Belgium, July 6, 2021 /PRNewswire/ -- Inbiose, a leading biotech company active in the development of Human Milk Oligosaccharides (HMOs), is pleased to announce that it has submitted its application for a Generally Recognized as Safe (GRAS) approval by the US Food & Drug Administration (FDA) of four HMOs, specifically 6'-Sialyllactose (6'SL), 3-Sialyllactose (3'SL), Lacto-N-Tetraose (LNT) and Lacto-N-neoTetraose (LNnT). Inbiose will also file for Novel Food approval of these HMOs by the Eu...

BIOVAXYS files FDA pre-IND meeting request and briefing package for COVID-T

VANCOUVER, BC, March 31, 2021 /PRNewswire/ -- BioVaxys Technology Corp. (CSE: BIOV) (FRA:5LB) (OTC:LMNGF) ("BioVaxys"), the world leader in haptenized antigen vaccines for antiviral and cancer applications, announced today that it is has filed a pre-IND (Investigational New Drug) meeting request and submitted a briefing package with the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) for Covid-T, its T-cell immune response diagnostic for SARS-CoV-2. The ...

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Covid, Gsk-Vir chiedono ok Usa a monoclonale: "Efficace su varianti"

GlaxoSmithKline e Vir Biotechnology hanno presentato all'Agenzia del farmaco americana Fda la richiesta di autorizzazione all'uso di emergenza (Eua) per Vir-7831 (Gsk4182136): "Un anticorpo monoclonale sperimentale contro Sars-CoV-2 a doppia azione, per il trattamento di adulti e adolescenti (di età pari o superiore a 12 anni con peso di almeno 40 kg) con Covid-19 da lieve a moderato, che sono a rischio di progressione verso il ricovero in ospedale o la morte". Lo annunciano le due aziende, sotto...

MedAlliance Receives Fourth FDA Breakthrough Device Designation for Sirolimus Drug-Eluting Balloon in Treatment of De Novo Coronary Lesions

NYON, Switzerland, March 4, 2021 /PRNewswire/ -- MedAlliance, the first drug-eluting balloon (DEB) company in the world to receive US Food and Drug Administration (FDA) Breakthrough Device Designation Status for a sirolimus DEB, has now been awarded breakthrough status for SELUTION SLR™, its sustained limus release DEB catheter, in the treatment of atherosclerotic lesions in native coronary arteries. This is the fourth breakthrough designation awarded to MedAlliance for its sirolimus DEB, followi...

JUD care Obtains FDA Approval for Its Portable Ward sRoom

SHENZHEN,China, Jan. 12, 2021 /PRNewswire/ -- JUD care, a leading high-tech enterprise in the field of smart medical and healthcare solutions, has obtained approval from the US Food and Drug Administration (FDA) for the portable ward sRoom ("sRoom"), a revolutionary solution for patient isolation that enables hospitals to quickly set up emergency isolation rooms.

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**Coronavirus: Nih, oggi vaccino Moderna a Fauci e sanitari in prima linea**

I National Institutes of Health (Nih) americani danno il via alle vaccinazioni anti-Covid per i sanitari in prima linea nella lotta contro la pandemia di coronavirus Sars-CoV-2. Durante un evento che sarà trasmesso in live streaming alle ore 10 locali (le 16 italiane), il vaccino di Moderna mRna-1273 verrà somministrato a 6 dipendenti dell'Nih Clinical Center alla presenza del segretario del Dipartimento di Salute e Servizi umani (Hhs) Alex M. Azar II, del direttore Nih Francis S. Collins, del di...

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Vaccino Moderna, via libera da Fda in Usa

La Food and Drug Administration ha autorizzato ufficialmente la distribuzione negli Stati Uniti di un secondo vaccino contro il coronavirus, quello di Moderna. Lo rende noto la stessa Fda su Twitter, spiegando che ''l'autorizzazione all'uso permette che il vaccino venga distribuito negli Stati Uniti per gli individui di età pari o superiore ai 18 anni''.

Small vessels can cause big problems; MagicTouch SCB Granted 'Breakthrough Device Designation' for the treatment of Small Coronary Artery Lesions

TAMPA, Fla., Dec. 17, 2020 /PRNewswire/ -- Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for the MagicTouch SCB Sirolimus Coated Balloon Catheter, for the treatment of small coronary artery lesions in Coronary Artery Disease (CAD).

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