Tag: Food and Drug Administration

US to add heart inflammation warning for Covid mRNA vaccines for teens – ET HealthWorld

Washington: US health authorities plan to update official guidance about administering mRNA Covid vaccines to adolescents and young adults after finding a likely link to rare cases of heart inflammation, but say the overall benefits still “clearly” outweigh the risks. The decision was announced during a meeting of experts convened by the Centers for Disease […]

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US to invest over $3 billion for Covid antiviral medicines – ET HealthWorld

WASHINGTON: The US government is investing more than $3 billion to accelerate the development and manufacturing of antiviral medicines to treat Covid-19, according to a statement by the Department of Health and Human Services (HHS). The plan, called the Antiviral Program for Pandemics, will respond to the urgent need for the antivirals by spurring the […]

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Thailand books 20 million doses of Pfizer-BioNTech Covid-19 vaccines – ET HealthWorld

Bangkok: Thailand has signed a purchase order for 20 million doses of the Covid-19 vaccine developed by Pfizer and BioNTech to be delivered before the end of this year, its health minister said. Details of the deal, delivery timeframe and the vaccine’s approval by the Food and Drug Administration would be worked out in about […]

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मॉडर्ना ने 12-17 साल के किशोर पर कोरोना वैक्सीन के आपात इस्तेमाल की अमेरिकी ड्रग रेगुलेटर से मांगी इजाजत

कोरोना वैक्सीन बनाने वाली दवा कंपनी मॉडर्ना अमेरिकी ड्रग्स रेगुलेटर फूड्स एंड ड्रग एडमिनिस्ट्रेशन से 12-17 आयुवर्ग के किशोरों के लिए आपात इस्तेमाल की मंजूरी मांगी है. ऐसा दूसरी बार है जब एफडीए से मॉडर्ना को वैक्सीन की मंजूरी मिलेगी. इससे पहले सभी वयस्कों पर मॉडर्ना वैक्सीन के इस्तेमाल की पहले ही इजाजत मिल चुकी […]

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USFDA grants approval for Aduhelm as the first and only Alzheimer’s drug in almost two decades – ET HealthWorld

CAMBRIDGE, Mass. and TOKYO, June 07, 2021 – Biogen and Eisai, Co., Ltd. today announced that the U.S. FDA has granted accelerated approval for Aduhelm™ (aducanumab-avwa) as the first and only Alzheimer’s disease treatment to address a defining pathology of the disease by reducing amyloid beta plaques in the brain. The accelerated approval has been […]

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Seeking a pill to cure Covid: drugmakers eye alternative to vaccines – ET HealthWorld

Prevention is better than cure — but when it comes to Covid, what happens when people can’t get the vaccine, don’t want it, or they’re immune suppressed and it fails to stop the infection? The hunt is on for a coronavirus treatment that can be taken as a pill soon after a confirmed positive, halting […]

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Biden boosting world vaccine sharing commitment to 80M doses – ET HealthWorld

President Joe Biden said Monday that the U.S. will share an additional 20 million doses of Covid-19 vaccines with the world in the coming six weeks as domestic demand for shots drops and global disparities in distribution have grown more evident. The doses will come from existing production of Pfizer, Moderna or Johnson & Johnson […]

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US looking at joint production of Johnson and Johnson’s Covid vaccine in India – ET HealthWorld

The US is looking at joint production of Johnson and Johnson‘s Covid-19 vaccine in India and ways to help manufacturers like the Serum Institute of India (SII) to boost production, Daniel B Smith, the Charge D’Affaires of the US embassy, said on Tuesday. Smith also said that the efficacy of AstraZeneca‘s Covid-19 vaccine manufactured at […]

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COVID-19: US authorises Pfizer-BioNTech vaccine shot for children aged between 12 and 15

New Delhi: “The light at the end of the tunnel is growing, and today it got a little brighter,” said President Joe Biden on Monday (May 10, 2021) after the United States Food and Drug Administration (FDA) expanded the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 vaccine to include adolescents. This, notably, is the first […]

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Crunching vaccine development timeline is a paradigm shift: Akshay Daftary – ET HealthWorld

By Akshay Daftary, Director, SIRO Clinpharm Vaccine – A mandatory transition From previous clinical data and trials, one can notice and understand that it takes around 10-15 years for the development of any vaccine against a virus or disease. The limitations caused due to the extended waiting period for the vaccines had to be broken […]

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