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12/11/2021

Biden will nominate industry-friendly Califf to lead U.S. FDA

WASHINGTON (Reuters) -President Joe Biden on Friday said he would nominate Robert Califf for a second stint as commissioner of

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09/11/2021

Pfizer set to ask FDA to OK booster for those 18 and older

(HealthDay)—Pfizer may soon seek U.S. Food and Drug Administration emergency authorization of its COVID-19 booster shot for anyone aged 18

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20/10/2021

FDA panel supports Moderna booster shot for older adults, people at high risk

(HealthDay)—Mirroring a similar recommendation issued last month for the Pfizer COVID-19 vaccine, an expert advisory panel to the U.S. Food

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20/10/2021

FDA panel endorses Moderna’s COVID-19 booster vaccine for certain high risk groups

FDA holds meeting to discuss Moderna vaccine booster A U.S. Food and Drug Administration (FDA) advisory panel on Thursday endorsed

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09/09/2021

U.S. FDA delays decision on Juul e-cigarettes

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August

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04/09/2021

FDA Approves Trudhesa

FDA Approves Trudhesa (dihydroergotamine mesylate) Nasal Spray for the Acute Treatment of Migraine SEATTLE, Sept. 03, 2021 (GLOBE NEWSWIRE) —

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28/07/2021

FDA Approves Semglee (insulin glargine-yfgn) as First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes

SILVER SPRING, Md., July 28, 2021 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product,

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10/07/2021

FDA head calls for inquiry into Alzheimer’s drug review

The acting head of the Food and Drug Administration on Friday called for a government investigation into highly unusual contacts

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08/07/2021

FDA trims use of contentious Alzheimers drug amid backlash

A month after approving a controversial new Alzheimer’s drug, U.S. health regulators on Thursday signed off on new prescribing instructions

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06/07/2021

Provention Bio shares tumble as U.S. FDA declines to approve diabetes drug

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August

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