Food and Drug Administration

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

10:21am January 05, 2023

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.

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.

Health & Safety

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

9:24am September 21, 2022

by Jon Hamilton

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.

A booster dose of the Moderna COVID-19 vaccine is prepared during a vaccination clinic on Dec. 29 in Lawrence, Mass. The FDA is now shortening the wait time between the second dose and the booster to five months from six months.

Health & Safety

FDA shortens the wait time between Moderna vaccine and booster to 5 months

2:01pm January 07, 2022

by Deepa Shivaram

Now, both the Pfizer and the Moderna booster shots can be given five months after the second dose of vaccine — down from six months.

Federal regulators have granted an emergency use authorization to the vaccine developed by Moderna, whose Cambridge, Mass., headquarters are seen here.

Health & Safety

Moderna's COVID-19 Vaccine Becomes 2nd To Earn FDA Authorization

8:26pm December 18, 2020

by Colin Dwyer

The Food and Drug Administration greenlights the biotech firm's vaccine for emergency use in the U.S. The move bolsters a vast inoculation effort that's already underway.

Health care workers have been throwing out the excess vaccine, fearing it would be against FDA rules to use it.

Some Vials Of COVID-19 Vaccine Contain Extra Doses, Expanding Supply

9:47pm December 16, 2020

by Vanessa Romo

"Given the public health emergency, FDA is advising that it is acceptable to use every full dose obtainable (the sixth, or possibly even a seventh) from each vial," the FDA said Wednesday.

An example of a vial that will carry the COVID-19 vaccine produced by Pfizer and BioNTech sits on display during a Senate subcommittee hearing Thursday.

Health & Safety

FDA Authorizes COVID-19 Vaccine For Emergency Use In U.S.

10:55pm December 11, 2020

by Colin Dwyer

Pfizer and BioNTech's vaccine is the first to receive an emergency authorization from the Food and Drug Administration. Officials say it may be ready for widespread inoculations within days.

A nurse prepares to administer the Pfizer-BioNTech COVID-19 vaccine at a hospital in London on Tuesday. The Food and Drug Administration is considering a recommendation to authorize the vaccine in the United States.

FDA Adviser: Vaccine To Be OK'd In Days, But 'Normal' May Not Return Until Next Fall

12:47pm December 11, 2020

by Noel King

The Food and Drug Administration's authorization of a COVID-19 vaccine could come in a day or two, a member of an FDA expert panel says. But he says it may be late 2021 before normalcy returns.

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The pharmaceutical giant Pfizer is formally requesting federal approval for emergency use of the company's COVID-19 vaccine

Health & Safety

Pfizer Asks FDA To Approve Its COVID-19 Vaccine For Emergency Use

11:59am November 20, 2020

by Colin Dwyer

The pharmaceutical giant and partner BioNTech announced Friday that they are submitting a formal request to the Food and Drug Administration, just days after the vaccine was shown to be 95% effective.

The Federal Trade Commission has sent warning letters to several companies that marketed the drug thymosin alpha-1 as a purported treatment for COVID-19. The Food and Drug Administration has never approved the drug for any condition.

Federal Trade Commission Cracks Down On Unproven COVID-19 Treatment

4:36pm November 12, 2020

by Tom Dreisbach

The Federal Trade Commission issued warning letters to several companies that marketed an unproven drug to treat COVID-19. Sales of the nonapproved drug, thymosin alpha-1, were first reported by NPR.

Food and Drug Administration Commissioner Stephen Hahn drew a hailstorm of criticism from scientists this week for mischaracterizing a study's findings in a way that hyped the benefits of convalescent plasma. He later apologized, but critics say the damag

FDA's Hahn Apologizes For Overselling Plasma's Benefits As A COVID-19 Treatment

7:15pm August 25, 2020

by Richard Harris

The Food and Drug Administration's chief said Sunday the therapy reduces deaths among COVID-19 patients by 35%. On Monday he apologized, acknowledging that statistic greatly exaggerates any benefit.