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The Latest Breaking News from Food and Drug Administration

A major drugmaker plans to sell overdose-reversal nasal spray Narcan over the counter

Emergent BioSolutions has applied to the Food and Drug Administration to sell the opioid overdose-reversal drug over the counter. Addiction experts say it may be a key step to lower fentanyl deaths.

WEKU

A new drug appears to slow Alzheimer’s. Here’s what to know

An experimental drug appears to slow cognitive decline in people with early onset Alzheimer’s.

Tribune News Service

Speedier drug approvals hit slowdown as FDA faces scrutiny

The Food and Drug Administration is slowing its use of a pathway that expedites the approval of promising drugs

The Independent UK

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Editorial: Thicker than sexuality: Let gay and bisexual men donate blood like anyone else

The Food and Drug Administration is on the cusp of changing rules so that more gay and bisexual men can donate blood like anyone else. It’s about time.

Tribune News Service

Study: Alzheimer's drug shows modest success slowing declines in memory, thinking

In a large study, the experimental Alzheimer's drug lecanemab reduced the rate of cognitive decline by 27 percent in people in the early stages of the disease.

WEKU

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

Bombay HC directs retest at 3 labs, permits J&J to manufacture baby powder at ‘own risk’ in the interim

MUMBAI: Directing a retesting of talc samples, the Bombay high court on Wednesday in an interim relief to Johnson and Johnson Pvt Ltd which is fighting a bar placed by the FDA, permitted it to manufacture its baby powder at the Mulund plant in Maharashtra at the company's "own risk,".

The Times of India

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Ketamine ‘saved my life’: Depressed, anxious Floridians turn to unregulated psychadelics

ORLANDO, Fla. — Ashley Blanco, 27, has grappled with anxiety, depression and obsessive-compulsive disorder for the better part of a decade. Antidepressants and therapy didn’t help. After she graduated college, the COVID-19 pandemic hit. It sent her mental health to an all-time low.

Orlando Sentinel

Provention Bio's Second Try, Apellis's Eye Disorder Drug Review, 3 Adcom Verdicts And More: November's Key PDUFA Catalysts Biotech Investors Must Know

Editor's note: This story has been corrected to reflect that the FDA deferred action on Amicus Therapeutics' Biologics License Application.

Benzinga

Parents warned about Dragon's Breath sweet

The treat known as Dragon's Breath, a liquid nitrogen-based sweet, should be treated with caution as it can potentially cause frostbite, Thailand's Food and Drug Administration (FDA) has warned.

Bangkok Post

Drug stores sold large amounts of cough syrup for drug cocktail

Police have raided a network of drug stores and arrested 20 employees for selling illegal amounts of cough syrup to adolescents for making a drug cocktail known as 4x100.

Bangkok Post

Will Californians Overrule the State's Intrusive Flavored Tobacco Ban?

Voters have shown a propensity to veto the meddlesome efforts of lawmakers in the past.

Reason

FDA delays advisory committee meeting on over-the-counter birth control pill

WASHINGTON — The Food and Drug Administration on Wednesday postponed a critical advisory meeting on an application for the nation’s first over-the-counter birth control pill, citing the need “to review new information.”

Tribune News Service

Dove, other Unilever dry shampoos recalled over cancer risk

Unilever Plc recalled popular brands of aerosol dry shampoo, including Dove, after discovering they were contaminated with a chemical called benzene that can cause cancer. The recall also covers brands such as Nexxus, Suave, Tresemmé and Tigi, which makes Rockaholic and Bed Head dry shampoos, according to a notice posted…

The Times of India

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The Independent UK

US clears Novavax COVID booster dose

The Food and Drug Administration has authorized a booster dose of the COVID-19 vaccine made by Novavax

WEKU

FDA chief touches on many issues during Lexington visit

The head of the Food and Drug Administration says more needs to be done in the area of treatment for pain. FDA Commissioner Robert Califf came to Lexington to participate in University of Kentucky Healthcare’s 60 Anniversary Symposium

Tribune News Service

Editorial: Florida surgeon general’s COVID vaccine ‘study’ is politics dressed up as science

This far into the pandemic, tens of millions of Americans have received mRNA COVID vaccines, following vast medical trials. The Centers for Disease Control and Prevention and the Food and Drug Administration continue to review the safety of the vaccines, part of what the CDC calls “the most intense safety…

Tribune News Service

For Alzheimer’s patients, a controversial drug brings hope

TAMPA, Fla. -- At 53, Michele Hall was at the height of her legal career. She’d just sent her three kids to college. She had decades ahead with her husband Doug — after nearly 30 years of marriage, the couple looked forward to celebrating 30 more.

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Bangkok Post

Häagen-Dazs ice cream worth B12m destroyed

Häagen-Dazs ice cream products worth 12 million baht were destroyed at an industrial facility in Samut Prakan on Monday although their samples were not found to be contaminated with traces of a chemical linked to a cancer.

Orlando Sentinel

Feds rebuke Florida surgeon general’s advice to young men on COVID vaccine

ORLANDO, Fla. — The Food and Drug Administration on Monday responded to the results of Florida Surgeon General Joseph Ladapo’s analysis of COVID-19 data that he says point to a risk for some men who get the shot.

Reuters

Doctors urge U.S. FDA to add miscarriage management to abortion pill label

Obstetricians, gynecologists, other medical professionals, and abortion rights advocates petitioned the U.S. Food and Drug Administration (FDA) on Tuesday to urge Danco Laboratories to seek approval of mifepristone, a pill used in terminating early pregnancies at home, for miscarriage management.

Ballotpedia

Federal Register weekly update: 1,378 pages added

The Federal Register is a daily journal of federal government activity that includes presidential documents, proposed and final rules, and public notices. It is a common measure of an administration’s regulatory activity, accounting for both regulatory and deregulatory actions.

Bangkok Post

Transgender influencer allegedly sold hazardous supplement

Police have arrested transgender influencer Nara Crepe Katoey on a charge of advertising dietary supplements containing a hazardous psychoactive drug, desoxy-D2PM.

Chicago Tribune

Commentary: Will we have a severe flu season? It doesn’t need to be that way

Flu season is fast approaching. Flu shots are now available, containing strains recommended by the Food and Drug Administration’s vaccine advisory committee in March. Given the long lead time required to manufacture some 180 million flu shot doses, scientists are forced to make informed guesses, a daunting task under the…

The Independent UK

Pfizer seeks to expand omicron booster to 5- to 11-year-olds

Pfizer is asking the Food and Drug Administration to expand use of its updated COVID-19 booster shot to children ages 5 to 11

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