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The Latest Breaking News from Food and Drug Administration

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

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

The Independent UK

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

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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…

Benzinga

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.

WEKU

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.

Tribune News Service

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…

Benzinga

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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.

WEKU

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…

Benzinga

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

The Independent UK

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.

WEKU

Florida chef’s pink sauce videos stir up TikTok backlash

Chef Pii’s tips on how to use her $20-a-bottle condiment have won 40m views, she says, but many wonder what goes into it

The Guardian - UK

What to know about Paxlovid, the COVID drug President Biden is using to speed recovery

Paxlovid has been highly effective at reducing the risks of hospitalization and death, but some patients report a "Paxlovid rebound," in which the disease returns.

WEKU

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Bangkok Post

Clinics now allowed to purchase, prescribe antiviral drugs

The Food and Drug Administration has given the green light for clinics to purchase and prescribe molnupiravir and other antiviral drugs for Covid-19 patients.

The Independent UK

FDA weighs oversight changes after Juul, formula troubles

The head of the Food and Drug Administration is commissioning an independent review of the agency’s food and tobacco programs

WEKU

Florida ice cream company Big Olaf recalls its products following a listeria outbreak

An outbreak in Big Olaf ice cream products that has sickened nearly two dozen people in 10 states forced the brand to recall all of its flavors and products, the Food and Drug Administration says.

Reason

States Must Allow Abortions When Woman's Health or Life Is Threatened, Says HHS

Plus: When "anti-wokeness" becomes an obsession, why immigrants are upwardly mobile, and more...

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The Independent UK

Production resumes at troubled Abbott baby formula factory

Abbot Nutrition says baby formula production has resumed at the Michigan plant whose February shutdown over contamination contributed to a national shortage

The Independent UK

FDA temporarily suspends order banning Juul cigarettes

The Food and Drug Administration has issued an administrative stay on the order it issued last month for vaping company Juul to pull its electronic cigarettes from the market

Bangkok Post

40 tonnes of drugs to go up in smoke this week

The Food and Drug Administration (FDA) and narcotics suppression authorities on Monday inspected more than 40 tonnes of confiscated illegal drugs worth over 34.6 billion baht before they are incinerated at a designated facility this week.

StockNews.com

As Covid Cases Decline, is it Time to Drop Pfizer?

Leading drug maker Pfizer (PFE) experienced robust growth over the past year primarily based on the growing demand for its Covid vaccine. However, as Covid cases decline, will the company be able to maintain its growth trajectory? Let’s find out.

WEKU

FDA says COVID boosters for the fall must target newer omicron types

With immunity waning and the super-contagious omicron family of variants getting better at dodging protection, the Food and Drug Administration decided boosters intended for fall needed an update.

Miami Herald

In briefing Congress, Fla. surgeon general admits state decision could limit vaccine access to kids

In a briefing to a congressional subcommittee Tuesday, Florida Surgeon General Joseph Ladapo confirmed that the state decision to block county health departments from obtaining COVID-19 vaccines for young children may prohibit an estimated 30,000 disadvantaged kids from obtaining access to the vaccines.

Benzinga

Pfizer, Moderna Analysts Respond To FDA COVID Booster Ruling: 'Revenues Will Decline'

The Food and Drug Administration’s panel of independent vaccine experts recently voted 19 to 2 to recommend a new batch of COVID-19 booster shots targeting the omicron variant this fall. The news, announced Tuesday, June 28, could have a big impact on the share prices of vaccine makers.

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