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The Latest Breaking News from FDA

Vet's lawsuit blaming antimalarial drug for psychosis tossed

A lawsuit against the maker of an anti-malarial drug blamed for causing psychotic and neurological damage in U.S. servicemembers has been thrown out

The Independent UK

Safety concerns hang over new Alzheimer's treatment

Two deaths linked to the drug may present a more complicated path to approval.

Axios

The chase is on: Regulators are slowly cracking down on vapes aimed at teens

The advent of vaping revived nicotine addiction among young people after a dramatic decline. The FDA seems poised to at last yank some products aimed at teens from the market. Will it work?

WEKU

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1 High-Dividend Stock to Add to Your Portfolio if You Haven’t Already

Amid prevalent COVID-19 cases, vaccine pioneer Pfizer (PFE) is significantly benefiting. Moreover, the company beat wall street expectations in the third quarter with a robust financial result and raised its revenue and EPS guidance for the year. Given its strong fundamentals, the stock could be a wise addition to your…

StockNews.com

Sarepta Surges As It Nears The Finish Line With A Muscular Dystrophy Gene Therapy

The FDA said Monday it will perform a speedy review of Sarepta Therapeutics' muscular dystrophy gene therapy, and SRPT stock jumped.

Investors Business Daily

NVI plans to utilise local booster shots

The National Vaccine Institute (NVI) plans to use locally developed Covid-19 vaccines as booster shots when they are completed and approved by the Food and Drug Administration (FDA).

Bangkok Post

3 Strong Buy Stocks to Continue to Hold Onto in 2023

As the Fed’s aggressive monetary policy resulted in slightly cooled inflation last month, investors are hopeful of smaller rate hikes ahead. However, since a recession is expected to hit the economy next year, we think fundamentally sound stocks Pfizer (PFE), Flowers Foods (FLO), and Xperi (XPER), which are rated Strong…

StockNews.com

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Come Next Thanksgiving, We Might Be Giving Thanks for Government-Approved, Lab-Grown Turkey

Regulators are beginning to smile on the sci-fi project of creating real meat products without the typical death and environmental destruction.

Reason

Psychedelic mushrooms expand Jamaica tourism beyond sunshine and reggae

A new group of Jamaican resorts is promoting tourism that offers mystical experiences and stress relief through "magic mushrooms," as the Caribbean nation seeks to develop a niche industry in natural psychedelics.

Reuters

Gene therapy at $3.5m a dose approved for US adults with hemophilia B

Hemgenix frees patients from repeated treatments but initial cost makes it most expensive medicine in the world

The Guardian - US

As STDs proliferate, companies rush to market at-home test kits. But are they reliable?

Among the more remarkable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry and consumers moved to make at-home testing a reliable tool for managing a public health crisis.

Tribune News Service

$3.5M gene therapy for hemophilia gets FDA approval

U.S. health regulators have approved the first gene therapy for hemophilia, a blood-clotting disorder with few treatment options

The Independent UK

‘This looks like the real deal’: are we inching closer to a treatment for Alzheimer’s?

After years of setbacks, dementia researchers are getting excited about a new antibody drug called lecanemab. No one expects it to stop cognitive decline, but even slowing it would be a breakthrough

The Guardian - UK

Era of hope for patients with lung cancer

November is Lung Cancer Awareness month. Lung cancer is the most common cancer worldwide, with more than 2.1 million cases, according to the American Lung Association.

Tribune News Service

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The Independent UK

Anti-abortion group that helped overturn Roe v Wade sues FDA to revoke approval of abortion drug

Conservative Christian group takes aim at abortion drug that is also used to treat miscarriages

Tribune News Service

Lawsuit seeks to reverse FDA approval of abortion-inducing pill mifepristone

AUSTIN, Texas — Abortion opponents on Friday asked a federal court to yank federal approval of a pill used to end pregnancies.

Investors Business Daily

Apellis Pharmaceuticals Surges On New Review Date For Eye-Disease Treatment

Apellis Pharmaceuticals said Friday the Food and Drug Administration will review its new eye-disease drug in February, and APLS stock surged.

The Guardian - UK

First Thing: Elon Musk shuts Twitter offices to staff after wave of resignations

The social media firm is struggling to retain workers after Musk demanded they sign a pledge committing to being ‘extremely hardcore’. Plus, lab-grown meat officially safe to eat in the US

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Los Angeles Times

Michael Hiltzik: The right wing gets its knives out for California's new medical misinformation law

Painfully aware of how attacks on COVID vaccines and anti-pandemic policies have undermined public health, California enacted a law this year that makes spreading medical misinformation and disinformation about the pandemic grounds for revoking a doctor's license.

The Guardian - US

US declares lab-grown meat safe to eat in ‘groundbreaking’ move

The government’s approval will open the market for a food praised for being more efficient and environmentally friendly

Reason

12 Republicans Support Same-Sex Marriage in Key Senate Vote

Plus: What Orion is carrying to the moon, when you might be able to munch on some lab-grown meat, and more...

Bangkok Post

FDA: Nasal spray product 'not anti-Covid'

The Food and Drug Administration (FDA) says it would take legal action against advertisements that mislead the public into believing that a nasal spray product can prevent or treat Covid-19.

Tribune News Service

Real-world evidence study of regenerative medicine and shoulder surgery

Applying regenerative medicine to a common shoulder surgery could have an impact on the need for follow-up revision surgery in some patients, according to a Mayo Clinic study of real-world evidence.

Asharq Al-Awsat

California Lab-grown Meat Start-up Gets First Green Light

A California-based lab-grown meat start-up received the first green light for such products from the US food safety agency on Wednesday, although the product still has more hurdles to clear before being sold to consumers. The US Food and Drug Administration said it carried out a "careful evaluation" of Upside…

AFP

California lab-grown meat start-up gets first green light

San Francisco (AFP) - A California-based lab-grown meat start-up received the first green light for such products from the US food safety agency on Wednesday, although the product still has more hurdles to clear before being sold to consumers.

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