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The Latest Breaking News from Food and Drug Administration

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

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

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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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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…

Tribune News Service

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.

The Conversation

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.

Chicago Sun-Times

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.

Tribune News Service

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…

The Conversation

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.

Bangkok Post

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…

Benzinga

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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…

Benzinga

Recap of Tuesday's Biotech Catalysts - End Of the Day Summary

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Relmada Therapeutics’ (NASDAQ:RLMD) lead asset REL-1017 as a monotherapy for the treatment major depressive disorder (MDD). Relmada shares traded in a range of $26.02 to $27.96 on a day volume of 173.79 thousand shares, closed regular trading…

WEKU

Lyons Magnus recalls 53 products including alternative milks and protein shakes

The products being recalled range from pre-made coffees to protein shakes and other nutritional beverages. Though no illnesses have been reported, the recalled products should be thrown out.

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Tribune News Service

Lisa Jarvis: At last, a simple strategy for COVID booster shots

The Food and Drug Administration reportedly has a new strategy for rolling out new booster shots that should bring needed clarity to COVID vaccination in the U.S. Going forward, most Americans will get the same advice about when to get their next shots.

Benzinga

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

The U.S. Food and Drug Administration (FDA) has cleared the Eledon Pharmaceuticals’ (NASDAQ:ELDN) Investigational New Drug (IND) application to evaluate Tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant. Eledon shares traded in a range of $2.89 to $3.16 on a day volume of 31.27 thousand…

WEKU

Banana Boat recalled a sunscreen spray after detecting trace amounts of a carcinogen

The maker of Banana Boat Hair & Scalp Sunscreen Spray SPF 30 said trace amounts of the cancer-causing chemical benzene were found in the propellant that sprays the product from the can.

Benzinga

Recap of Wednesday's Biotech Catalysts - End of The Day Summary

IDEAYA Biosciences (NASDAQ:IDYA) has entered into a clinical trial collaboration and supply agreement with Amgen Inc. to evaluate the efficacy and safety of IDE397 with Amgen's AMG 193 in a Phase 1 clinical trial. IDEAYA shares traded in a range of $14.59 to $15.82 on a day volume of 130.58…

The Independent UK

FDA chief's long-promised opioid review faces skepticism

The head of the Food and Drug Administration says a comprehensive review of the opioid painkillers that triggered the nation's ongoing overdose epidemic is in the works

WEKU

5 things to know about the FDA's flawed approach to accelerated drug approvals

An NPR investigation found stalled confirmatory trials and lax enforcement are plaguing the FDA's accelerated approval of drugs for urgent medical needs.

WEKU

Drugmakers are slow to prove medicines that got a fast track to market really work

Stalled confirmatory trials and lax enforcement plague the Food and Drug Administration's accelerated approval pathway for pharmaceuticals that target urgent medical needs.

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