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News Articles: FDA

An expected change in FDA policy would make it easier for men who have sex with men to donate blood.

FDA moves to ease restrictions on blood donations for men who have sex with men

Long criticized as discriminatory, the policy has prevented many gay and bisexual men from donating blood. The Food and Drug Administration revealed a draft of its new approach on Friday.

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By:
  • Rob Stein and
  • Will Stone
A nurse prepares a syringe of a COVID-19 vaccine at an inoculation station in Jackson, Miss., in 2022. An advisory committee for the FDA voted Thursday to simplify the country's approach to COVID vaccination.

An FDA committee votes to roll out a new COVID vaccination strategy

Advisers to the U.S. Food and Drug Administration today endorsed a proposal to make big changes in the nation's approach to vaccinating people against COVID-19.

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By:
  • Scott Hensley
Boxes of the drug mifepristone sit on a shelf at the West Alabama Women's Center in Tuscaloosa, Ala., on March 16, 2022. Lawsuits have been filed in West Virginia and North Carolina challenging the states' restrictions on the use of abortion pills.

New lawsuits target state restrictions on abortion pills

Supporters of abortion rights have filed separate lawsuits challenging abortion pill restrictions in North Carolina and West Virginia. The lawsuits were filed Wednesday.

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By:
A staff member for Sen. Rand Paul takes photos of her puppy, Jefferson, before a 2021 press conference on the FDA Modernization Act.

The FDA no longer requires all drugs to be tested on animals before human trials

In a victory for animal rights advocates, drugmakers can take their products to human clinical trials using alternative testing methods that don't involve animals.

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By:
  • Joe Hernandez
U.S. health officials approved Leqembi, a new Alzheimer's drug that modestly slows the brain disease. The FDA granted accelerated approval Friday for patients in early stages of Alzheimer's.

FDA approves Alzheimer's drug that appears to modestly slow disease

An Alzheimer's drug that removes the substance amyloid from the brain has received a conditional approval from the FDA. A large study found the drug decreased the loss of thinking and memory by 27%.

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By:
  • Jon Hamilton
The Food and Drug Administration announced it has loosened some restrictions on the pill mifepristone, allowing it to be dispensed by more pharmacies and without an in-person exam.

Abortion pills should be easier to get. That doesn't mean that they will be

Changes by the FDA mean patients won't have to schedule in-person exams to get a prescription. That opens the door for more pharmacies to provide the medication. But not everyone will have access.

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By:
  • Vanessa Romo and
  • Sydney Lupkin
Boxes of the drug mifepristone sit on a shelf at the West Alabama Women's Center in Tuscaloosa, Ala., on March 16, 2022.

The FDA finalizes rule expanding the availability of abortion pills

The Food and Drug Administration on Tuesday finalized a rule change that broadens availability of abortion pills to many more pharmacies, including large chains and mail-order companies.

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By:
  • The Associated Press
Food and Drug Administration (FDA) signage is seen through a bus stop at the U.S. Department of Health and Human Services, Thursday, Aug. 2, 2018, in Silver Spring, Md., on the FDA grounds.

Food safety will rely on better traceability data, says new FDA rule

Harvesters, processors, manufacturers and others in the food chain have three years to comply with the new record keeping system, effective next month

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By:
Nearly two years after the FDA issued a policy denouncing the marketing of fruit-flavored vape juice and other vape products to young people, the products are still widely available in stores. But experts hope that could be about to change.

The chase is on: Regulators are slowly cracking down on vapes aimed at teens

The advent of vaping revived nicotine addiction among young people after a dramatic decline. The FDA seems poised to at last yank some products aimed at teens from the market. Will it work?

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By:
  • Yuki Noguchi
In this Aug. 2, 2018, file photo, the U.S. Food and Drug Administration (FDA) building is visible behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md.

The FDA has officially declared a shortage of Adderall

The FDA has confirmed the nation is experiencing a shortage of Adderall after many pharmacies around the country have been unable to fill prescriptions and keep up with demand.

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By:
  • Ayana Archie
A controversial new drug for ALS that just received FDA approval could add months to patients' lives, but some scientists question whether it actually works.

ALS drug's approval draws cheers from patients, questions from skeptics

A controversial new drug for ALS could add months to patients' lives – if it actually works

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By:
  • Jon Hamilton
The drugmaker Amylyx is asking the FDA to approve a new medication for ALS, a fatal neurodegenerative disease. It's possible the agency could greenlight the drug by the end of the month.

FDA seems poised to approve a new drug for ALS, but does it work?

In March, experts who advise the FDA questioned the efficacy of an experimental new drug for ALS. In September, they voted to approve it anyway.

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By:
  • Jon Hamilton
Vials of the newly reformulated COVID-19 vaccine booster are being readied by Pfizer for distribution now that the Food and Drug Administration has authorized the shots for people 12 and older.

FDA authorizes first revamp of COVID vaccines to target omicron

The new shots from Moderna and Pfizer-BioNTech target both the original strain of the coronavirus and the omicron BA.4/BA.5 subvariants that most people are catching now.

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By:
  • Scott Hensley and
  • Rob Stein
A new rule from the Food and Drug Administration could allow some American adults to buy hearing aids without costly doctor's visits as soon as October.

Millions of Americans will soon be able to buy hearing aids without a prescription

A new FDA rule allows adults with perceived mild to moderate hearing loss to buy hearing aids over the counter. Efforts to make them more affordable and accessible have been in the works for years.

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By:
  • Rachel Treisman
Kristi Alcayaga's teenage son, Michael, was able to try a cancer drug called clofarabine that got an accelerated approval from the Food and Drug Administration. But the medicine didn't help him.

5 things to know about the FDA's flawed approach to accelerated drug approvals

An NPR investigation found stalled confirmatory trials and lax enforcement are plaguing the FDA's accelerated approval of drugs for urgent medical needs.

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By:
  • Sydney Lupkin