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FDA says its safety review of abortion pill will continue into next year

WASHINGTON | The Food and Drug Administration says its ongoing safety review of the nation’s main abortion pill will continue into next year, a timeline that was quickly condemned by abortion opponents hoping to see the drug’s use curtailed. The FDA gave a court-ordered update on its progress in a legal filing late Wednesday, providing […]

8 mins read

CDC vaccine policy recommendations grind to a halt under Health Secretary Kennedy

NEW YORK | The Food and Drug Administration recently approved a new flu vaccine that tested well in older adults. But the federal agency responsible for telling doctors and the general public how to use it has made no recommendation on it. The Centers for Disease Control and Prevention’s inaction on the mFlusiva vaccine marks […]

8 mins read

Cyclospora outbreak followed years of declining FDA foreign inspections

WASHINGTON | A nationwide outbreak of cyclospora tied to contaminated lettuce has heightened safety concerns about imported food, while underscoring a longer-term trend: U.S. regulators are conducting fewer international inspections to catch contaminated produce before it lands on American plates. Food and Drug Administration inspections of foreign food sites — including the Mexican farm linked […]

7 mins read

Cyclospora outbreak followed years of declining FDA foreign inspections

WASHINGTON | A nationwide outbreak of cyclospora tied to contaminated lettuce has heightened safety concerns about imported food, while underscoring a longer-term trend: U.S. regulators are conducting fewer international inspections to catch contaminated produce before it lands on American plates. Food and Drug Administration inspections of foreign food sites — including the Mexican farm linked […]

7 mins read

Trump officials propose new requirements for food additives and ingredients

WASHINGTON | U.S. health officials on Monday proposed a rule change that would require food manufacturers to notify regulators before introducing new ingredients or additives into processed or packaged foods. The proposal would change a decades-old policy that advocates have called a regulatory loophole, blaming it for allowing thousands of unvetted ingredients into the U.S. […]

3 mins read

New kind of flu shot is on the way as the FDA approves Moderna’s mRNA-based vaccine

WASHINGTON | The Food and Drug Administration has approved a new kind of flu vaccine for older people, the first made with the same mRNA technology that was key to ending the COVID-19 pandemic, manufacturer Moderna said. The shot, named mFlusiva, is intended for adults age 50 or older. Other brands of flu shots already […]

4 mins read

FDA still focused on lettuce supplier as source of parasite, despite faulty test result

WASHINGTON | Federal health officials said Monday they remain focused on lettuce from Taylor Farms as the source of a multistate outbreak of a diarrhea-causing parasite, despite inaccurate test results that the government briefly publicized over the weekend. Food and Drug Administration officials on Monday said a laboratory test incorrectly identified a positive result for […]

3 mins read

FDA approves a first-of-its-kind pill to cut cholesterol in high-risk patients

WASHINGTON | The Food and Drug Administration has approved a first-of-its-kind pill that can drastically reduce cholesterol in a way that’s previously only been available with expensive, injectable drugs. The drug from Merck was OK’d on Thursday for patients with artery-clogging cholesterol that persists even after taking statins, the standard medications for cutting heart attack […]

4 mins read

FDA’s e-cigarette authorization: Fruity vapes not significantly better than tobacco ones

WASHINGTON | Fruit-flavored e-cigarettes recently authorized by the Food and Drug Administration were not significantly better at helping smokers quit than tobacco-flavored e-cigarettes, according to a new memo that’s likely to stir more questions about the agency’s decision. The FDA last month gave its first OK to fruit-flavored vapes — essentially endorsing them as a […]

8 mins read

FDA staff blindsided by move allowing more e-cigarettes and nicotine pouches onto US market

WASHINGTON | Senior officials in the Food and Drug Administration’s tobacco center were blindsided by a recent decision that opens the door to allowing more unauthorized electronic cigarettes and nicotine pouches onto the U.S. market, The Associated Press has learned. The guidelines, posted online earlier this month before former FDA Commissioner Marty Makary resigned, will […]