Food and Drug Administration

No Increased Stroke Risk Linked to Pfizer’s Covid Boosters, Federal Officials Say

Fears that the Covid booster shots made by Pfizer-BioNTech may increase the risk of strokes in people aged 65 and older were not borne out by an intensive scientific investigation, federal officials said on Friday. “It is very unlikely” that the risk is real, the officials said. They urged Americans 6 months and older to […]

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R.J. Reynolds Pivots to New Cigarette Pitches as Flavor Ban Takes Effect

R.J. Reynolds has wasted no time since California’s ban on flavored tobacco went into effect in late December. “California, We’ve Got You Covered,” the company declared in bold letters on a flier mailed to its cigarette customers. The law prohibits flavors, odors or “tastes” in tobacco products, including menthol cigarettes. But antismoking experts argue that […]

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F.D.A. Authorizes Updated Covid Shots for Children as Young as 6 Months

WASHINGTON — The Food and Drug Administration on Thursday expanded eligibility for the updated coronavirus shots to children as young as 6 months old, the latest step to make the retooled doses available to more Americans. The federal government rolled out the updated boosters from Pfizer-BioNTech and Moderna in September, though the public has shown […]

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U.S. Moves to Stretch Out Monkeypox Vaccine Supply

WASHINGTON — The Biden administration has decided to stretch out its limited supply of monkeypox vaccine by allowing a different method of injection that uses one-fifth as much per shot, according to people familiar with the discussions. In order for the Food and Drug Administration to authorize so-called intradermal injection, which would involve injecting one-fifth […]

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Officials Wrestle With Whether to Allow New Monkeypox Vaccination Strategy

WASHINGTON — It sounded like a simple solution to the shortage of monkeypox vaccine: Merely by changing the way doses are injected, the federal government could vaccinate five times as many people with the supply it has in hand. But the approach — injecting one-fifth of the current dose into the skin instead of a […]

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As Monkeypox Spreads, U.S. Declares a Health Emergency

Gay rights activists, who have been sharply critical of the administration, have been demanding an emergency declaration for weeks. “This is all too late,” said James Krellenstein, a founder of PrEP4All, an advocacy group that works to expand treatment for people with H.I.V. “I don’t really understand why they didn’t do this weeks ago.” The […]

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Biden Administration Plans to Offer Updated Booster Shots in September

WASHINGTON — The Biden administration now expects to begin a Covid-19 booster campaign with retooled vaccines in September because Pfizer and Moderna have promised that they can deliver doses by then, according to people familiar with the deliberations. With updated formulations apparently close at hand, federal officials have decided against expanding eligibility for second boosters […]

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Biden Administration May Offer Second Coronavirus Boosters to All Adults

WASHINGTON — The Biden administration is considering whether to expand second coronavirus booster shots to adults under 50 in an effort to counter the latest, highly contagious variant, which has driven up hospitalization rates and deepened worries about waning immunity among those vaccinated or boosted at least six or so months ago. Expanding eligibility for […]

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F.D.A. to Weigh Over-the-Counter Sale of Contraceptive Pills

WASHINGTON — More than 60 years after the approval of oral contraceptives revolutionized women’s sexual health, the Food and Drug Administration has received its first application for a birth control pill over the counter — just as the Supreme Court’s decision to overturn Roe v. Wade has put access to contraception more squarely at the […]

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