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The Latest Breaking News from Food and Drug Administration

FDA authorizes first COVID booster for children ages 5 to 11

The Food and Drug Administration expanded authorization of Pfizer-BioNTech's COVID vaccine to enable kids ages 5 to 11 who were vaccinated at least five months ago to get a third shot.

WEKU

US Baby Formula Crisis Could See Some Relief As FDA, Abbott Agree On Deal

The baby formula shortage that has morphed into a crisis in the U.S. could soon see some relief following an agreement between market leader Abbott Laboratories (NYSE: ABT) and the Food and Drug Administration.

Benzinga

Deal reached to reopen baby formula plant, Abbott says

The company, headquartered in Chicago, did not immediately detail terms of the agreement with the Food and Drug Administration, which has been investigating safety concerns at the firm’s Sturgis, Michigan, plant.

Chicago Sun-Times

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Top-Rated Eli Lilly Nears Breakout After FDA Approves Its Next Potential Blockbuster

The Food and Drug Administration approved an Eli Lilly diabetes drug it described as "novel," prodding LLY stock closer to a breakout.

Investors Business Daily

FDA chief says shuttered baby formula plant could reopen soon, offering hope to ease shortage

The head of the Food and Drug Administration said Monday that a shuttered baby formula factory should reopen within two weeks, potentially easing a serious nationwide shortage.

Tribune News Service

White House bolsters efforts to get baby formula into the hands of WIC recipients

States have been asked to increase accessibility of baby formula for recipients of the low-income program. And the Food and Drug Administration is looking at ways to make it easier to import formula.

WEKU

Imported infant formula could help lift U.S. supply in weeks -FDA chief

The Food and Drug Administration will outline a plan next week to streamline imports of infant formula, the agency's chief said on Friday, adding that the action along with others would "help dramatically improve the supply in the U.S. in a matter of weeks."

Reuters

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Editorial: A looming battle over abortion pills threatens cherished freedoms

Following the leak of a draft majority opinion, expectations run high that the U.S. Supreme Court soon will overturn the 1973 Roe v. Wade decision affirming the constitutional right of women to abortion, and we have an idea of what abortion foes will target thereafter: pills.

Chicago Tribune

Abbott says two months for baby formula to hit shelves amid US shortage

US manufacturer forced to close Michigan plant after reports of illness and death that prompted federal investigation

The Guardian - US

This at-home COVID-19 test could give you a wrong result. Don’t use it, FDA warns

WASHINGTON — The Food and Drug Administration is warning to avoid using another at-home COVID-19 that could give a wrong result when used.

McClatchy Washington Bureau

What's The FDA's Regulatory Impact On The Cannabis Industry? Find Out In This Webinar

What's the Food and Drug Administration's impact on the cannabis industry?

Benzinga

Thailand providing free cannabis plants for home cultivation

Thailand’s public health minister says the government will distribute 1 million cannabis plants free when most legal restrictions on production and possession of the drug are lifted next month

The Independent UK

Thailand's first lot of local Covid vaccine produced

The first batch of ChulaCov19, the first messenger-RNA vaccine developed in Thailand, has been produced and is awaiting Food and Drug Administration (FDA) approval for the first two phases of human trials, a government spokesperson said on Saturday.

Bangkok Post

US Drug Regulator Limits Use of J&J Covid Vaccine

The US said Thursday only adults who "have personal concerns" about mRNA vaccines, access issues or medical reasons for refusing them may now receive the Johnson & Johnson Covid shot, which has been linked to a rare but serious clotting condition. The vaccine, which was authorized as a single shot,…

Asharq Al-Awsat

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Los Angeles Times

Commentary: COVID won’t become endemic until we have a vaccine for kids under 5

Last week, Moderna became the first manufacturer to officially ask the Food and Drug Administration to approve its COVID-19 vaccine for children under 6 years old. One of three companies with authorized COVID-19 vaccines in the United States, Moderna made the request a month after saying its data showed efficacy…

Reason

The End of Roe? Everything You Need To Know About the Leaked Supreme Court Draft Opinion

Plus: Boston rebuked for rejecting Christian flag, Google will remove more personal information, and more...

Axios

Pressure builds for COVID vaccines approval for littlest kids

Moderna's request for approval of its COVID -19 vaccine in children under six years amps up pressure on the Food and Drug Administration to act quickly to approve the shots.

Tribune News Service

Editorial: The FDA rightly moves to extinguish menthol cigarettes

The Food and Drug Administration has proposed banning menthol-flavored cigarettes, potentially beginning in 2024. It’s a tragedy that it is taking this long, but it’s never too late to save a life — or in this case, potentially hundreds of thousands of lives.

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Investors Business Daily

Novavax Surges As Its Covid Shot Approaches The FDA Finish Line

The Food and Drug Administration said Friday its panel of experts will discuss Novavax's Covid vaccine in June, leading NVAX stock to surge.

AFP

US drug regulator schedules infant Covid vaccine meeting for June

Washington (AFP) - The US Food and Drug Administration on Friday announced it would hold a set of meetings on Covid vaccines in June that would include deciding whether to authorize them for the youngest children.

The Independent UK

FDA sets June meetings on COVID vaccines for youngest kids

The Food and Drug Administration has set tentative dates in June to publicly review COVID-19 vaccines for the youngest American children

Tribune News Service

FDA proposes ban on menthol cigarettes, flavored cigars

WASHINGTON — The Food and Drug Administration on Thursday proposed a long-awaited ban on menthol cigarettes and flavored cigars, targeting products used by more than a third of smokers.

Benzinga

SQZ Biotechnologies Receives FDA Fast Track Designation for SQZ-PBMC-HPV for the Treatment of HPV16+ Tumors

SQZ Biotechnologies (NYSE: SQZ) received Fast Track Designation from he U.S. Food and Drug Administration (FDA) for its lead cell therapy candidate, SQZ-PBMC-HPV, for the treatment of HPV16+ advanced or metastatic solid tumors. SQZ-PBMC-HPV-101 is currently being investigated in the Phase 1/2 clinical study.

The Independent UK

McKinsey exec faces questions on opioid, FDA consulting work

A top McKinsey executive is answering congressional questions about his company’s consulting work for the Food and Drug Administration even as it advised opioid drugmakers on boosting sales

Salon

Another delay for five-and-under vaccine

The issue isn't around safety, but instead messaging and vaccine effectiveness

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