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MYSTERIOUS: 7 - What They Never Told You

Probe: Alzheimer's drug approval 'rife with irregularities'

The Food and Drug Administration's contentious approval of a questionable Alzheimer's drug is taking another hit

The Independent UK

House report questions FDA’s approval of Alzheimer’s drug

WASHINGTON — A joint investigation released Thursday by House Democrats identified unusual collaboration between Food and Drug Administration officials and drugmaker Biogen, highlighting potential problems in the agency’s approval of the controversial Alzheimer’s drug Aduhelm.

Tribune News Service

FDA changes Plan B label to clarify 'morning-after' pill doesn't cause abortion

The agency in a memo Friday said the emergency contraception pills are not the same as abortion pills — which end a pregnancy — a fact that has long been understood in the medical community.

WEKU

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FDA changes Plan B label, clarifies it won't cause abortion

The Food and Drug Administration announced Friday that it will overhaul packaging labels for the emergency contraceptive pill, Plan B, that women can take after having sex to prevent a pregnancy

The Independent UK

ALS patients contend with $158K price tag on new drug

For two years, Becky Mourey pushed the Food and Drug Administration to approve an experimental drug for her Lou Gehrig’s disease

The Independent UK

Onslaught of new abortion restrictions looms in reddest of states

New state legislative sessions likely to bring fresh efforts to restrict, penalize or altogether ban the procedure

The Guardian - US

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

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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

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

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

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Benzinga

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.

Bangkok Post

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.

Reason

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.

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Tribune News Service

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.”

The Times of India

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 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.

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.

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