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The Latest Breaking News from Food and Drug Administration

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

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

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

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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

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.

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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.

Bangkok Post

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…

Chicago Tribune

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

The Independent UK

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.

WEKU

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.

Tribune News Service

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

Daily Mirror

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.

Benzinga

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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…

Los Angeles Times

Michael Hiltzik: In blow to public health, judge tosses FDA lawsuit targeting a clinic offering unproven stem cell treatments

A federal judge in Riverside, California, declared a stem cell treatment firm operating in the state to be exempt from Food and Drug Administration regulations, opening the door to the further proliferation of clinics offering therapies the FDA says are scientifically unproven and potentially dangerous.

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Benzinga

Bluebird bio Seeks Back-to-Back Nods, 'Go' or 'No-Go' For Revance's Botox Rival, Amylyx' Twin Hurdles And More: September's Key PDUFA Catalysts Biotech Investors Must Know

After August’s mixed tally for Food and Drug Administration approvals, investors turn to a new month, which has a fairly loaded calendar.

Roll Call

FDA greenlights new COVID-19 booster despite limited data - Roll Call

The Food and Drug Administration granted emergency authorization to Pfizer and Moderna for updated COVID-19 booster shots.

Tribune News Service

FDA to approve new omicron COVID-19 boosters

The Food and Drug Administration is set to approve new boosters that specifically target the omicron mutation of COVID-19.

The Independent UK

FDA chief says long-awaited opioid review still in the works

The head of the Food and Drug Administration says a government review of prescription opioid medications, including their risks and contribution to the U.S. overdose epidemic, is still underway

Bangkok Post

32 tonnes of impounded drugs to be destroyed

Thirty-two tonnes of seized illicit drugs will be incinerated at the Akkhie Prakarn Plc factory in Bang Pu Industrial Estate, Samut Prakan province, on Aug 30-31, Food and Drug Administration (FDA) secretary-general Paisal Dankhum said on Tuesday.

Benzinga

Vaping Companies Are Thumbing Their Noses At FDA Rules And Getting Away With It

The Food and Drug Administration is determined to crack down on businesses that sell vaping products without its approval since e-cigarettes and e-liquids that contain nicotine have been considered a prescription-only medicine since 2021, reported STAT.

Chicago Sun-Times

Congressman’s wife died after taking herbal remedy white mulberry leaf marketed for weight loss, diabetes

“Many people assume if that product is sold in the United States of America, somebody has inspected it, and it must be safe,” U.S. Sen. Dick Durbin, D-Ill., said when he introduced legislation to strengthen oversight of dietary supplements. “Unfortunately, that’s not always true.”

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