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The Latest Breaking News from Food and Drug Administration

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

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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

US clears Novavax COVID booster dose

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

The Independent UK

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Why Novavax's Uphill Battle Continues Despite Winning U.S. Booster Authorization

Novavax won Food and Drug Administration for its Covid booster on Wednesday, but NVAX stock dipped slightly in response.

Investors Business Daily

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

WEKU

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.

Tribune News Service

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.

Bangkok Post

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.

Orlando Sentinel

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.

Reuters

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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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WEKU

Here's what the FDA says contributed to the baby formula shortage crisis

The Food and Drug Administration rattled off 15 reasons behind the national baby formula shortage, but couldn't identify a specific person or agency responsible.

Tribune News Service

Lawmakers strike deal on FDA user fee bill

WASHINGTON — Senate committee leaders have struck an agreement to reauthorize five-year user fee deals for the Food and Drug Administration, although details of a broader stopgap government spending bill remain unfinished.

Daily Mirror

Breast cancer risk due to implants explained as FDA warns about potential link

Breast cancer and breast implants link has been shrouded with anecdotal doubts and theories. Recently, the Food and Drug Administration has issued a statement pertaining to this

Benzinga

FDA Okays bluebird bio's $3M Gene Therapy For Rare Neurological Disorder In Boys: What Investors Should Know

Biotechnology company, bluebird bio, Inc. (NASDAQ: BLUE) announced late Friday that the Food and Drug Administration approved its gene therapy for a rare neurodegenerative disease.

Los Angeles Times

Michael Hiltzik: This life-saving drug will cost a record $2.8 million. Who will pay the price?

For the estimated 1,500 Americans suffering from a blood disorder known as beta thalassemia, the Food and Drug Administration's approval Aug. 17 of the drug Zynteglo was almost unalloyed good news.

The Independent UK

ALS drug gets rare second review at high-stakes FDA meeting

The Food and Drug Administration is holding an unusual second meeting to review a closely watched drug for the illness known as Lou Gehrig’s disease

The Conversation

Will omicron-specific booster shots be more effective at combating COVID-19? 5 questions answered

On Sept. 1, 2022, the Centers for Disease Control and Prevention endorsed the use of updated COVID-19 booster shots that are specifically tailored to combat the two most prevalent omicron subvariants, BA.4 and BA.5. The decision comes just a day after the Food and Drug Administration’s emergency use authorization of…

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