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The Latest Breaking News from Food and Drug Administration

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.

Los Angeles Times

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 Independent UK

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…

The Conversation

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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.

Los Angeles Times

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.

Benzinga

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.

Roll Call

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.

Tribune News Service

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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

The Independent UK

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.

Bangkok Post

These 10 Non-Covid Biotech Stocks Are Up 40% Or More This Year

Biotech stocks are scorching right now. But the best of the best have strong gains. Those include 10 with at least 40% growth this year.

Investors Business Daily

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.

Benzinga

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.”

Chicago Sun-Times

US House panel slams Trump’s COVID response; report mentions early role from Mehmet Oz

Mehmet Oz’s advocacy for the drug hydroxychloroquine in the early days of the COVID-19 pandemic is cited in a new congressional report that accuses former President Donald Trump’s administration of pressuring the Food and Drug Administration to endorse unproven treatments and vaccines.

The Philadelphia Inquirer

Advocates urge FDA action to ease policing fears in menthol ban

WASHINGTON — Experts and advocates are calling on the Biden administration to do more to avoid potential confrontations between police and racial minorities if the Food and Drug Administration finalizes a ban on menthol cigarettes.

Tribune News Service

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Tribune News Service

What Mayo Clinic experts want you to know about over-the-counter hearing aids

The Food and Drug Administration has cleared the way for the sale of over-the-counter hearing aids, making it possible for consumers to purchase these instruments without medical exams or fittings as soon as this fall. It will likely mean cost savings, but what should those with hearing issues know before…

The Conversation

Over-the-counter hearing aids have been greenlighted by the FDA – your local pharmacist will soon be able to sell you the device you need

After a long delay, the Food and Drug Administration issued final regulations Aug. 16, 2022, for over-the-counter hearing aids. The final rule is effective 60 days from its publication, meaning that consumers could see OTC hearing aids hitting the shelves of community pharmacies nationwide by October 2022.

Investors Business Daily

Why Pharvaris Stock Crashed — And Why At Least One Analyst Isn't Worried

Biotech stock Pharvaris plummeted Monday after the Food and Drug Administration placed a pair of its clinical studies on hold.

Chicago Sun-Times

Hearing aids OK’d for over-the-counter sale starting in October, prices expected to fall

The Food and Drug Administration said the new regulation creates a new class of hearing aids that don’t require a medical exam or prescription. They’ll be sold online or over-the-counter at pharmacies and other stores.

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Investors Business Daily

Axsome Wins A 60-Year First In Depression; And Shares Catapult 40%

The Food and Drug Administration approved a new depression pill from Axsome Therapeutics on Friday, and AXSM stock catapulted higher.

Tribune News Service

FDA finalizes over-the-counter hearing aid rule

WASHINGTON — The Food and Drug Administration on Tuesday finalized a rule making hearing aids for people with mild to moderate hearing loss available without requiring them to see a doctor.

The Conversation

Wellness vapes: what you need to know about vaping vitamins and other supplements

So-called wellness vapes are growing in popularity. Unlike regular vapes (e-cigarettes) that contain nicotine, these products contain vitamins, hormones or essential oils. But they have caught the attention of the US Food and Drug Administration (FDA) because of the unproven health claims made by many of the companies that sell…

Bangkok Post

No Häagen-Dazs recall in Thailand - FDA

Certain batches of Häagen-Dazs ice cream products that have been found to be contaminated with traces of a chemical linked to cancer have not been imported into Thailand, Food and Drug Administration (FDA) deputy secretary-general Weerachai Nolwachai said on Saturday.

Benzinga

Recap Of Thursday's Biotech Catalysts - End Of the Day Summary

The U.S. Food and Drug Administration (FDA) has accepted the Menarini Group and Radius Health’s (NASDAQ:RDUS), New Drug Application (NDA) for elacestrant for patients with ER+/HER2- advanced or metastatic breast cancer. The agency has granted Priority Review designation and assigned a target action date of February 17, 2023. Radius Health…

The Independent UK

Monkeypox vaccine maker warns Biden administration against strategy to stretch supply

Plan to multiply 440,000 doses into 2 million is ‘safe and effective’ and will go ahead says HHS secretary

Benzinga

Recap Of Wednesday's Biotech Catalysts - End Of the Day Summary

Bristol Myers Squibb (NYSE:BMY) and 2seventy bio (NASDAQ:TSVT) announced positive topline results from KarMMa-3, a Phase 3 study evaluating Abecma (idecabtagene vicleucel) compared to standard combination regimens in adults with multiple myeloma that is relapsed and refractory. Bristol Myers shares traded in a range of $73.95 to $75.32 on a day volume…

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