FDA reportedly hopes to fully approve Pfizer’s Covid vaccine by Labor Day

3 August 2021 - Federal regulators are aiming to grant full approval to Pfizer’s coronavirus vaccine by early September, the New ...

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The FDA finally gets moving on Pfizer

2 August 2021 - The agency will now ‘sprint’ to grant full vaccine approval. ...

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FDA under pressure to grant full approval to COVID-19 vaccines

1 August 2021 - Some schools, hospitals and employers are hesitant to mandate vaccines while shots are still only authorized for ...

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FDA authorises REGEN-COV monoclonal antibody therapy for post-exposure prophylaxis for COVID-19

30 July 2021 - The U.S. FDA today revised the emergency use authorisation for REGEN-COV (casirivimab and imdevimab, administered together) authorising ...

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FDA says it's working as fast as possible to fully approve vaccines, as urgency rises amid COVID-19 surge

29 July 2021 - The US FDA insists it is working as quickly as possible to review applications for full ...

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FDA authorizes baricitinib alone as treatment for COVID-19

28 July 2021 - Today, the U.S. FDA revised the Emergency Use Authorisation for baricitinib (Olumiant) now authorising baricitinib alone for ...

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FDA asks Pfizer, Moderna to test their vaccines in more children to help rule out safety issues

26 July 2021 - Federal regulators have requested that vaccine companies expand their trials to test coronavirus shots in several ...

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Full FDA approval is needed to overcome vaccine hesitancy

26 July 2021 - As the Delta variant spreads, what is the agency waiting for? ...

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U.S. FDA grants priority review for the biologics license application for Pfizer-BioNTech COVID-19 vaccine

16 July 2021 - Pfizer and BioNTech today announced that the U.S. FDA granted priority review designation for the biologics license ...

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FDA to announce new warning on J&J COVID vaccine related to a rare auto-immune disorder, report says

12 July 2021 - About 100 preliminary reports of Guillain-Barre syndrome have been detected after 12.8 million doses of the J&J ...

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Experts warn full FDA COVID-19 vaccine approval is no quick fix for hesitancy

12 July 2021 - The FDA issuing full approval for two COVID-19 vaccines might not be the game changer it’s ...

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Pfizer plans to request FDA approval for COVID booster shot in August

9 Jul 2021 - Pfizer plans to request US emergency authorisation in August for a third booster dose of its ...

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It’s time for the FDA to fully approve the mRNA vaccines

1 July 2021 - Here’s a paradox: a new drug for Alzheimer’s disease, aducanumab, gets approved by the FDA through an ...

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United States to spend $4.2 billion on anti-viral pills and other treatments for COVID-19

18 June 2021 - The United States is devoting $US3.2 billion ($4.2 billion) to speed development of antiviral pills to treat ...

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A life-saving new drug for COVID-19 is found

16 June 2021 - But only rich countries will benefit, and even they will struggle to get hold of it. ...

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