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The Latest Breaking News from Food and Drug Administration

Advisers to the FDA back Novavax COVID vaccine

Advisers to the Food and Drug Administration overwhelmingly voted to recommend that it authorize Novavax's two-dose vaccine against COVID-19.

WEKU

US move affects Africa's vax drive

The US Food and Drug Administration's recent decision to limit the use of the Johnson & Johnson Covid-19 vaccine to adults who cannot or will not get another vaccine will have profound consequences for African countries. The FDA said its move reflected the risk that the vaccine might cause a…

Bangkok Post

US FDA Concerned over Potential Novavax Myocarditis Risk

The Food and Drug Administration voiced concern Friday about myocarditis being potentially linked to the Novavax Covid-19 vaccine, just as experts are to weigh its use in the United States. The Novavax vaccine is already authorized in other countries, particularly in Europe. In the United States, an independent committee convened…

Asharq Al-Awsat

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White House says COVID vaccination for kids younger than 5 could start in a few weeks

COVID-19 vaccinations for children younger than 5 could start right after the Juneteenth holiday.

WEKU

Pfizer Seeks FDA Approval For Three Covid Vaccine Doses For Children Below Five

Partners Pfizer, Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) urged the FDA to authorize three vaccine doses for children below five, the Wall Street Journal reports. The companies previously asserted that three doses of the shot were 80% effective at preventing symptomatic Covid-19 with robust immune response in children between six months to five years. After mixed results…

Benzinga

FDA launching website, app for registration of cannabis, hemp cultivation

The Food and Drug Administration is launching a phone app and a website for people to register their cultivation of cannabis and hemp plants, which are being removed from the category 5 narcotics list, FDA deputy secretary-general Withid Sariddeechaikool said on Wednesday.

Bangkok Post

Attention Biotech Investors: Mark Your Calendar For These June PDUFA Dates

May turned out to be a month of mixed fortunes as far as regulatory reviews are concerned. New molecular entity approvals, an indicator of innovation in drug research, totaled three during the month, bringing the total for the year to 15. This compares to the 24 NMEs the Food and…

Benzinga

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Delta-8 Cannabis Compound Is Legal, Says Federal Appeals Court

Plus: Libertarian Party changes abortion and bigotry planks, the FDA's weird rejection of fluvoxamine for treating COVID-19, and more...

Reason

Health Ministry, agencies aim to deter recreational weed use

The Public Health Ministry has signed an agreement with eight agencies to emphasise the use of cannabis and hemp for medical, beauty and research and development use amid fears people will use it for recreational purposes when they are allowed to grow the plants at home from June 9.

Bangkok Post

How important is the COVID-19 booster shot for 5-to-11-year-olds? 5 questions answered

COVID-19 case numbers are rising again in the U.S. – including among children. In mid-May 2022, the Food and Drug Administration authorized a booster shot of the COVID-19 vaccine for U.S. children ages 5 to 11, and the Centers for Disease Control and Prevention followed by recommending a booster shot…

The Conversation

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

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

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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.

Tribune News Service

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.

The Independent UK

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

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Tribune News Service

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.

WEKU

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.

Benzinga

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.

Chicago Sun-Times

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.

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.

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