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10/12/2020

U.S. FDA Accepts for Priority Review the Biologics License Application for Pfizer’s Investigational 20-valent Pneumococcal Conjugate Vaccine for Adults 18 Years of Age and Older

NEW YORK–(BUSINESS WIRE)– December 08, 2020 Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted

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09/12/2020

FDA Approves Saxenda (liraglutide) for the Treatment of Obesity in Adolescents Aged 12-17

PLAINSBORO, N.J., Dec. 4, 2020 /PRNewswire/ — Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved an updated label

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28/10/2020

Alexion Receives FDA Approval for New Advanced Formulation of Ultomiris (ravulizumab-cwvz) with Significantly Reduced Infusion Time

BOSTON–(BUSINESS WIRE)–Oct. 12, 2020– Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced the U.S. Food and Drug Administration (FDA) has approved Ultomiris

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27/10/2020

FDA Authorises Restart of the COVID-19 AZD1222 Vaccine US Phase III Trial

23 October 2020  — Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed across the world with regulators

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22/10/2020

FDA Approves Veklury

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19 FOSTER CITY, Calif.–(BUSINESS WIRE)–Oct. 22, 2020– Gilead Sciences, Inc. (Nasdaq: GILD)

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16/10/2020

Pregnancy warning extended for common pain relievers, FDA says

Pregnant women worry about childbirth during COVID-19 pandemic Fox News correspondent Laura Ingle reports. The FDA said it will require

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29/09/2020

Over 2 decades, the FDA consistently approved new opioids based on studies lacking critical safety and efficacy data

Over the past 2 decades, data submitted to the U.S. Food and Drug Administration (FDA) for new opioid approvals has

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04/09/2020

Coronavirus vaccine could get emergency approval before critical testing is complete, FDA says

The head of the U.S. Food and Drug Administration says that coronavirus vaccines may be given emergency approval before rigorous

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18/08/2020

FDA flags accuracy issue with widely used coronavirus test

Potential accuracy issues with a widely used coronavirus test could lead to false results for patients, U.S. health officials warned.

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05/02/2020

FDA gives emergency green light for the CDC's coronavirus test

FDA gives emergency green light for the CDC’s coronavirus test to be used in more labs in major step toward

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U.S. FDA Accepts for Priority Review the Biologics License Application for Pfizer’s Investigational 20-valent Pneumococcal Conjugate Vaccine for Adults 18 Years of Age and Older

FDA Approves Saxenda (liraglutide) for the Treatment of Obesity in Adolescents Aged 12-17

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