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FDA panel recommends Pfizer vaccine for children 5 to 11
2021-10-27 Mark Gualtieri Health News

FDA advisory panel recommends use of Pfizer COVID vaccine in children aged 5 – 11 who could start receiving it by end of next week

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Merck to ask FDA for emergency approval of its new antiviral pill for COVID
2021-10-02 Mark Gualtieri Health News

(HealthDay)—Pharmaceutical giant Merck & Co. said Friday that it will seek federal approval for emergency use of its new antiviral pill molnupiravir, after a clinical

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FDA delays decision on e-cigarettes from vaping giant Juul
2021-09-09 Mark Gualtieri Health News

Federal health officials on Thursday delayed a high-stakes decision on whether to permit bestselling vaping brand Juul to stay on the market, while banning the

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FDA approves nasal spray to treat migraines, promising ‘efficacy on demand’
2021-09-09 Mark Gualtieri Health News

Impel NeuroPharma, a Seattle-based biopharmaceutical company, received approval from the U.S. Food and Drug Administration last week for its novel nasal spray that treats migraine

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U.S. FDA seeks new warnings on arthritis drugs from Pfizer, Lilly and AbbVie
2021-09-02 Mark Gualtieri Health News

(Reuters) -The U.S. drug regulator has asked Pfizer, Eli Lilly & Co and AbbVie to include information about the risks of serious conditions and death

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U.S. FDA declines to approve Sesen Bio's bladder cancer treatment
2021-08-13 Mark Gualtieri Health News

(Reuters) – The U.S. Food and Drug Administration has declined to approve Sesen Bio Inc’s lead therapy candidate for a type of bladder cancer, the

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Pediatrics group urges FDA OK of COVID-19 vaccines in younger kids
2021-08-10 Mark Gualtieri Health News

Dr. Saphier: CDC still not giving accurate portrayal of COVID risk to children Fox News medical contributor Nicole Saphier joins ‘America’s Newsroom’ to provide insight

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FDA Approves Pradaxa (dabigatran) as First Oral Blood Thinning Medication for Children
2021-06-21 Mark Gualtieri Health News

June 21, 2021 — Today, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than

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U.S. FDA declines to approve Avenue's IV formulation of painkiller
2021-06-14 Mark Gualtieri Health News

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo(Removes

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FDA Weighs Approval of a Lucrative Alzheimer’s Drug but Benefits Are Iffy
2021-06-04 Mark Gualtieri Health News

The Food and Drug Administration’s decision next week whether to approve the first treatment for Alzheimer’s disease highlights a deep division over the drug’s benefits

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