The Latest Breaking News from FDA

Pfizer and BioNTech said Tuesday they are seeking emergency authorization from US health regulators for use of their Covid vaccine for children aged over six months and under five years. If the Food and Drug Administration (FDA) authorizes the two-shot regimen, it will become the first Covid vaccine available to…

Pfizer Inc. and partner BioNTech SE have begun submitting data to U.S. regulators for authorization of their COVID-19 vaccine in children 6 months to 4 years old, according to people familiar with the matter, hastening an effort to get shots to younger kids after the omicron wave caused pediatric infections…

The FDA has approved ViiV Healthcare's Apretude (cabotegravir extended-release injectable suspension

Vaccine may be available to youngsters below the age of five from February, if FDA approval is granted

After a fairly robust 2021, the new year started on a mixed note as far as regulatory decisions are concerned.

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Pfizer is expected to submit a request to the FDA as soon as tomorrow for emergency-use authorization.

WASHINGTON — Moderna Inc.’s vaccine for COVID-19 received full approval from the U.S. Food and Drug Administration for people 18 and older, an important milestone that bolsters the shot’s use as a major weapon against the virus.

Ex-actor and Reclaim Party leader latest right-wing personality to promote treatment most commonly used as anti-parasitic for livestock after testing positive for coronavirus

Getting vaccines approved for the youngest children would not only be a relief for worried parents, but could help protect against disruptive school and daycare closures.

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