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The Latest Breaking News from the Food and Drug Administration

Moderna Stock Rises After FDA Application For Updated Vaccine

Moderna's potential beyond COVID-19 is underappreciated, says analyst Eliana Merle, who upgraded the stock to Buy

Zenger

An Alzheimer's drug is on the way, but getting it may still be tough. Here's why

The Food and Drug Administration is expected to grant full approval to the Alzheimer's drug lecanemab by July 6. But access to the drug may still be limited.

WEKU

FDA warns stores to stop selling Elf Bar, the top disposable e-cigarette in the U.S.

The warning from the Food and Drug Administration is the latest attempt by regulators to crack down on illegal disposable vapes that have poured into U.S. stores in recent years.

WEKU

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Are masks for the birds? We field reader queries about this new stage of the pandemic

The official emergency is over but COVID is still here. And that means ... lots of questions. We asked our readers what's on their mind and then called on experts for advice.

WEKU

FDA advisers back updated COVID shots for fall vaccinations

A panel of advisers to the Food and Drug Administration has recommended revising the current COVID-19 vaccine so that it specifically targets omicron.

WEKU

FDA advisers endorse new RSV antibody drug for babies

A panel of experts to the Food and Drug Administration has recommended the agency approve a long-acting antibody drug that can protect infants from the seasonal virus, RSV.

WEKU

The FDA approved a new drug for hot flashes. Here's why it shows 'a lot of promise'

The Food and Drug Administration last Friday approved fezolinetant, or Veozah, to treat hot flashes for women in menopause. The non-hormonal drug treatment is the first of its class and represents an option for women who cannot take hormones.

Tribune News Service

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Commentary: By avoiding funding Alzheimer’s research, the government is cutting seniors’ life spans

Millions of patients and their caregivers breathed a collective sigh of relief when drugmaker Eli Lilly recently announced its new experimental Alzheimer’s medication appears to slow cognitive decline by 35%. The Food and Drug Administration could approve the new treatment, donanemab, as soon as this year.

Chicago Tribune

FDA advisers support approval of RSV vaccine to protect infants

At least 58,000 childern younger than 5 years old are hospitalized each year with RSV infections. A Pfizer vaccine given to pregnant people could help protect their infants from severe RSV illness.

WEKU

Doctors Detail Dangerous Pregnancy Care in States With Abortion Restrictions

Plus: APA says social media not inherently harmful for kids, senators propose Artificial Intelligence Regulatory Agency, and more...

Reason

New menopause drug for hot flashes gets FDA approval

The Food and Drug Administration has approved a new type of drug to treat hot flashes caused by menopause

The Independent UK

CNN Gave Trump a Megaphone and He Used It Exactly as You'd Expect

Plus: American conservatives are becoming more European, FDA approves birth control "mini pill" for over-the-counter sale, and more...

Reason

Advisers to the FDA back first over-the-counter birth control pill

In a unanimous vote, 17-0, a panel of advisers to the Food and Drug Administration recommended that the agency approve the first over-the-counter birth control pill.

WEKU

The FDA considers first birth control pill without a prescription

The Food and Drug Administration is weighing whether to allow a birth control pill to be sold over the counter for the first time. An advisory committee opens a two-day hearing Tuesday.

WEKU

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LiveScience

Don't use 'amniotic fluid' eye drops, FDA warns

"Amniotic fluid" eye drops aren't approved and could be harmful, the Food and Drug Administration warned.

WEKU

Here's what really happened during the abortion drug's approval 23 years ago

A Texas judge ruled that the Food and Drug Administration wrongly approved mifepristone in 2000 and accused it of doing a rush job. Here's what really went down.

Tribune News Service

Commentary: Abortion pill ruling means more painful, later terminations

The conservative 5th Circuit has blocked part of a Texas judge’s decision to pull abortion drug mifepristone off the market, but leaves in place onerous and outdated restrictions that the Food and Drug Administration determined in 2016 were medically unnecessary.

St. Louis Post-Dispatch

Editorial: Judge had a basis for his attack on FDA, but not regarding mifepristone

The chiefs of more than 400 pharmaceutical companies signed a scathing letter this week blasting federal Judge Matthew Kacsmaryk’s ruling that the Food and Drug Administration had overstepped its authority in approving the abortion-inducing drug mifepristone. The letter was more than justified and, while harshly worded, accurately recounted Kacsmaryk’s abysmal…

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The Guardian - US

To protect abortion access, the FDA should decline to enforce a mifepristone ban

Try as it might, the Food and Drug Administration cannot escape the abortion debate. The agency must be bolder

Tribune News Service

Big tobacco targets Black smokers with menthol but FDA plans a ban

ATLANTA — The Food and Drug Administration has taken up the regulation of tobacco products as a key issue to focus on in 2023, particularly prohibiting the sale of menthol cigarettes and flavored cigars and cigarillos.

Los Angeles Times

Commentary: A judge’s attempt to restrict medication abortion nationwide shows extremists aren’t done yet

On Friday, federal Judge Matthew Kacsmaryk handed down a decision further restricting abortion access nationwide by suspending the Food and Drug Administration’s approval of mifepristone, the most common and safe pill used for medication abortion. Another ruling, from a federal judge in Washington state, ordered the F.D.A. to make no…

WEKU

Medication abortion is still possible with just one drug. Here's how it works

A judge's ruling puts access to the abortion drug mifepristone in limbo, pending further court decisions. But there's another drug that is safe and effective at ending early pregnancy.

Evening Standard

US abortion pill access in doubt after Texas judge suspends approval

Abortion medication mifepristone has been available in the US for more than 20 years

France 24

US access to abortion pill mifepristone in limbo after conflicting judicial rulings

Access to the most commonly used method of abortion in the U.S. plunged into uncertainty Friday following conflicting court rulings over the legality of the abortion medication mifepristone that has been widely available for more than 20 years.

Los Angeles Times

Abortion pill ruling: Texas judge orders hold on FDA approval, but another judge contradicts him

ATLANTA — A federal judge in Texas delivered a major blow to reproductive rights advocates Friday, ordering a hold on the Food and Drug Administration approval of mifepristone, an abortion medication used in the United States since 2000.

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