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The Latest Breaking News from Food and Drug Administration

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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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…

Los Angeles Times

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...

Reason

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.

Axios

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.

Tribune News Service

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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.

Investors Business Daily

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

The Independent UK

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.

Tribune News Service

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.

Benzinga

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

The Independent UK

Another delay for five-and-under vaccine

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

Salon

1st COVID treatment for kids under 12 gets FDA approval. What to know about Veklury

The Food and Drug Administration approved Veklury — also known as the drug remdesivir — as the first COVID-19 treatment for children younger than 12 on Monday, April 25.

McClatchy Washington Bureau

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Benzinga

Why Quoin Pharmaceuticals Stock Is Trading Higher

Quoin Pharmaceuticals (NASDAQ: QNRX) shares are trading higher Monday after the company announced it received U.S. Food and Drug Administration clearance to initiate clinical testing for its Investigational New Drug application for QRX003.

Investors Business Daily

Axsome Therapeutics' Good Fortune Reverses As Its Migraine Drug Hits A Hurdle

Axsome Therapeutics expects the Food and Drug Administration to reject its migraine treatment, leading AXSM stock to crumble on Monday.

Benzinga

Why AlloVir Stock Is Surging Today

AlloVir Inc (NASDAQ: ALVR) shares are trading higher Wednesday after the company announced the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy designation to its lead investigational multi-virus-specific T cell therapy, posoleucel.

Ballotpedia

Checks and Balances: SEC publishes proposed climate disclosures rule

The Checks and Balances Letter delivers news and information from Ballotpedia’s Administrative State Project, including pivotal actions at the federal and state levels related to the separation of powers, due process, and the rule of law.

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Evening Standard

GlaxoSmithKline and AstraZeneca secure victories with US drug regulator

GlaxoSmithKline’s drug aimed at chronic kidney disease patients with anaemia and AstraZeneca’s lung cancer treatment have both moved a step closer to getting the green light

Dynamite News

COVID-19: First breathing test for detecting Coronavirus is authorized by FDA

The Food and Drug Administration (FDA) authorized the first test, InspectIR COVID-19 Breathalyzer, to detect COVID-19 through the breath for emergency use. Full story on Dynamite News:

The Independent UK

FDA authorizes 1st breath test for COVID-19 infection

The Food and Drug Administration has issued an emergency use authorization for what it says is the first device that can detect COVID-19 in breath samples

The Independent UK

E-cigs using synthetic nicotine come under FDA oversight

The Food and Drug Administration says it will begin cracking down on e-cigarettes that have used synthetic nicotine to skirt oversight

Chicago Tribune

Commentary: Is a second booster for COVID-19 the right choice for you?

The Food and Drug Administration and the Centers for Disease Control and Prevention recently authorized a second booster shot of the Pfizer/BioNTech and Moderna COVID-19 vaccines for those age 50 and older. The recommendation follows a study out of Israel recently published in The New England Journal of Medicine.

Chicago Tribune

New type of cigarette that ‘helps you smoke less’ debuts in Chicago stores this week, amid some controversy

Cigarettes that recently gained authorization from the Food and Drug Administration to be marketed as products that can help smokers cut back are hitting Chicago-area stores this week — the first place in the country where they will be sold.

Benzinga

Why Biofrontera Stock Is Surging Today

Biofrontera Inc (NASDAQ: BFRI) shares are trading significantly higher Wednesday after the company announced it received U.S. Food and Drug Administration approval for its cGMP laboratory in Germany.

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