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The Latest Breaking News from Food and Drug Administration

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

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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

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.

Bangkok Post

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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.

Benzinga

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

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.

Investors Business Daily

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

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

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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…

Reason

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...

Bangkok Post

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.

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The Conversation

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…

Benzinga

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.

Tribune News Service

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.

The Independent UK

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

WEKU

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.

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