Sunday, May 19, 2024

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— William Wilberforce

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Texas Man and Dairy Cattle Test Positive for Bird Flu

avian flu test

A man in Texas has tested positive for the H5N1 bird flu after direct exposure to infected dairy cattle. While this is the second recent case of bird flu identified in humans in the United States, it is the first time the disease has been found in dairy cattle.1 The first case of H5N1 in […]

Pfizer, Moderna Apply for EUA for COVID Shots for Infants, FDA to Decide Quickly

mother holding baby

On June 1, 2022, Pfizer and BioNTech submitted an application to the U.S. Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) to distribute their messenger RNA (mRNA) BNT162b2 (also known as “Comirnaty”) COVID-19 biologic for children as young as six months to five years old. The application is for a three-dose regimen, […]

The FDA Has a History of Rushed Drug Approvals

FDA approved

Two weeks ago, the Pfizer COVID-19 vaccine was reported as the first COVID-19 vaccine to receive full approval from the U.S. Food and Drug Administration (FDA) for individuals aged 16 and older.1 But, for some, questions remain regarding conflicting discrepancies of the wording surrounding the approval.2 While the FDA’s report states that full approval was […]

Novartis Manipulated Data in FDA Biologics License Application

licensing

On Aug. 6, 2019, the U.S. Food and Drug Administration (FDA) issued a statement saying that Swiss pharmaceutical company Novartis AG submitted a biologics license application (BLA) for the spinal muscular atrophy (SMA) gene therapy Zolgensma (onasemnogene abeparvovec-xioi) with manipulated data and failed to inform regulators until June 28, 2019—more than a month after the […]

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