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The Latest Breaking News from Food and Drug Administration

The FDA knows nicotine is addictive. It wants to regulate it for the first time

The Food and Drug Administration is poised to set a maximum nicotine level in cigarettes and some other tobacco products, looking to make them less addictive and wean smokers off the habit.

WEKU

Juul e-cigarettes officially banned in the US

The US Food and Drug Administration announced on Thursday that the company ‘must stop selling and distributing these products’

The Independent UK

Biden administration to call for nicotine reductions in cigarettes

New policy forcing tobacco companies to cut nicotine to nonaddictive amounts could upend industry

The Independent UK

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Doctors ‘thrilled’ to order COVID vaccines for young kids after DeSantis changes course

MIAMI — Pediatricians across Florida have begun ordering COVID-19 vaccines for their patients under 5 after Gov. Ron DeSantis changed course Friday and allowed doctors and hospitals in the state to get them from a federal program.

Miami Herald

Covid vaccines may soon be approved for young children in the US – will Australia do the same?

Moderna and Pfizer vaccine trials for children six months to five years old look promising and experts say the TGA is likely to approve both

The Guardian - AU

Baby formula company stops production again due to storms

It is unclear when the facility will restart production

The Independent UK

Abbott's baby formula plant closes again after severe storms and flooding

Abbott's Sturgis, Mich., plant was open for less than two weeks before it had to close again after flooding from severe weather. The company said it hopes to resume production in a few weeks.

WEKU

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Access, hesitancy loom over COVID-19 vaccine rollout for toddlers - Roll Call

Adults had plenty of opportunities to get their COVID-19 vaccines. But it won't be as easy for those under age of 5.

Roll Call

FDA Advisors Back Moderna's Covid Shot For Children As Young As 6

Advisors to the FDA unanimously Tuesday recommended expanding Moderna's Covid vaccine to children as young as 6.

Investors Business Daily

Lilly-Incyte Snag FDA Nod For Patchy Hair Loss Treatment — Smaller Rival's Stock Shoots Up In Sympathy

Alopecia areata, an autoimmune disorder that causes patchy hair loss, now has a new treatment that has been approved by the Food and Drug Administration.

Benzinga

US Approves First Pill for Treatment of Alopecia

The Food and Drug Administration on Monday approved a drug called baricitinib as the first oral tablet for treating severe alopecia areata, an autoimmune disorder affecting more than 300,000 people in the United States every year. Alopecia causes either temporary or permanent patchy hair loss that can affect any hair-bearing…

Asharq Al-Awsat

Moderna shot 'works in kids 6 months and up'

Moderna Inc's Covid-19 vaccine is effective in children and adolescents, with mostly mild to moderate side effects, the United States Food and Drug Administration staff said.

Bangkok Post

We're Looking At Obesity In A New Way — And 4 Pharmaceutical Stocks Could Benefit

A group of pharmaceutical stocks are climbing as they pivot their diabetes drugs to help treat obesity. A potential multibillion-dollar market beckons them.

Investors Business Daily

Mayo Clinic Minute: What to expect with COVID-19 vaccinations for youngest kids

The Food and Drug Administration (FDA) could grant emergency use authorization of a COVID-19 vaccination for the youngest kids later this month. Pfizer asked the agency to review data and authorize its COVID-19 vaccine for children ages 6 months to 5 years.

Tribune News Service

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Bangkok Post

Kingdom decriminalises ganja

More than 150,000 people registered to cultivate cannabis with the Food and Drug Administration (FDA) on Thursday as the decriminalisation of the plant took effect.

Bangkok Post

Over 100,000 people register to grow cannabis

More than 100,000 people registered to cultivate cannabis via the application and website of the Food and Drug Administration on Thursday morning as the legalisation of cannabis and hemp took effect.

Benzinga

What's Next For Novavax Stock As COVID Vaccine Clears Key Hurdle In US

After last week's scare stirred by the release of the Food And Drug Administration's briefing documents, Novavax (NASDAQ: NVAX) can now heave a sigh of relief.

WEKU

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.

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Investors Business Daily

Novavax Stock Jumps After FDA Advisors Endorse Its Covid Shot

An FDA panel voted nearly unanimously in favor of Novavax's Covid shot on Tuesday. After yo-yoing Wednesday, NVAX stock settled up.

Bangkok Post

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…

Asharq Al-Awsat

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…

WEKU

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.

Benzinga

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…

Bangkok Post

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.

Benzinga

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…

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