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The Latest Breaking News from Food and Drug Administration

Elevation Oncology Shares Gain On FDA Fast Track Designation For Seribantumab In Tumor-Agnostic Settings

Elevation Oncology, Inc. (NASDAQ: ELEV) received Fast Track designation from the Food and Drug Administration (FDA) for Seribantumab in tumor-agnostic settings for the treatment of advanced solid tumors that harbor NRG1 gene fusions.

Benzinga

Millions of imported baby formula cans are heading to the US, FDA says

Millions more cans of baby formula will be available in the U.S. in the coming months, the nation’s Food and Drug Administration said, detailing steps it’s taken to alleviate a shortage that has left families scrambling to figure out how to feed their babies.

Tribune News Service

FDA chief to detail delays inspecting baby formula plant

The head of the Food and Drug Administration is preparing to tell lawmakers about events that led to a months-long gap before inspecting the plant at the center of a nationwide baby formula shortage

The Independent UK

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If Pfizer's data pans out, when will little kids get the COVID-19 vaccine?

Pfizer plans to submit new data to the Food and Drug Administration this week, bringing families with young children one step closer to a long-awaited vaccine.

WEKU

Jif peanut butter is being recalled for potential salmonella contamination

The J.M. Smucker Co. announced the recall on Friday. The Food and Drug Administration says current epidemiologic evidence points to a Lexington, Ky., facility as the likely cause of the outbreak.

WEKU

The CDC is urging a Pfizer booster for children ages 5 to 11

The Centers for Disease Control and Prevention's advice opens a third COVID-19 shot to healthy elementary-age kids — just like what is already recommended for everybody 12 and older.

WEKU

Abbott baby formula factory could reopen by next week, FDA head says

An Abbott baby formula plant in Michigan that’s been shut down since February could be up and running as early as next week, the head of the Food and Drug Administration told lawmakers Thursday.

Tribune News Service

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FDA faces congressional scrutiny over baby formula shortage

The head of the Food and Drug Administration is facing congressional lawmakers for the first time over the national shortage of baby formula

The Independent UK

Viewpoint 3: To avoid the next infant formula crisis, make food safety a priority

The Food and Drug Administration has reached an agreement with Abbott Laboratories to resume production at the company’s Sturgis, Michigan, facility. The announcement gives hope of relief for the three-fourths of American parents who rely on infant formula, and have struggled to find the product in recent weeks.

Tribune News Service

Q&A: A parents’ guide to COVID booster shots for kids 5-11

SAN JOSE, Calif. -- With COVID-19 cases rising again in the Bay Area, parents have a new consideration for protecting their children this week: The Food and Drug Administration granted emergency use authorization Tuesday for kids ages 5-11 to get a booster shot of Pfizer’s COVID-19 vaccine.

Tribune News Service

Biden invokes the Defense Production Act for the baby formula shortage

Biden is also authorizing the Defense Department to use commercial aircraft to fly formula supplies that meet federal standards from overseas to the U.S.

WEKU

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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Tribune News Service

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.

WEKU

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.

Reuters

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."

Chicago Tribune

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.

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The Guardian - US

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

McClatchy Washington Bureau

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.

Benzinga

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?

The Independent UK

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

Bangkok Post

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.

Asharq Al-Awsat

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,…

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…

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