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FDA Approves Apretude, the First Injectable PrEP Medication—Here’s Why That’s a Big Deal

The Food and Drug Administration has approved the first injectable pre-exposure prophylaxis (PrEP) medication to lower the risk of getting HIV through sex, the agency announced on Monday. Previously, PrEP had only been available in pill form. The new medication, called Apretude (cabotegravir extended-release injectable suspension) is given first as two injections one […]

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Coronavirus (COVID-19) Update: FDA Expands Eligibility for COVID-19 Vaccine Boosters

Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. The […]

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FDA expands emergency authorization for Covid-19 booster shots to all adults

The Food and Drug Administration expanded the emergency use authorization for the Pfizer and Moderna Covid-19 vaccine boosters on Friday, signaling that the shots can be given to anyone aged 18 or older at least six months after completion of the primary vaccine series. The new policy still requires signoff […]

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FDA authorizes the COVID-19 vaccine from Pfizer and BioNtech for kids 5 to 11

Pfizer plans to begin shipping millions of vials of the pediatric vaccine — with orange caps to avoid mix-ups with the purple-capped doses for everyone else — to doctors’ offices, pharmacies and other vaccination sites. WASHINGTON (AP) — The Food and Drug Administration on Friday paved the way for children […]

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Panel de la FDA avala la vacuna de Pfizer antiCovid para niños de 5 a 11 años

Washington.- Un comité asesor de la Administración de Alimentos y Fármacos (FDA, en inglés) de Estados Unidos recomendó este martes la aprobación de la vacuna contra la Covid-19 de Pfizer para menores de entre 5 y 11 años. Tras más de siete horas de reunión, los expertos de este órgano consultivo dieron luz verde a la […]

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FDA Approves Cell-Based Flu Shot for Ages 6 Months and Older

The Food and Drug Administration has approved the Flucelvax quadrivalent vaccine for use in children aged 6 months and older, according to a statement from manufacturer Seqirus. “This approval officially allows all eligible Americans to receive a cell-based influenza vaccine, increasing the potential for greater vaccine effectiveness,” according to the company. The Centers for […]

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