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The Latest Breaking News from FDA

Morning Brief: Top Financial Stories Dominating on Wednesday, May 18

CNBC Toyota Looks To Develop Hydrogen Mobility In Europe

Benzinga

Why is the FDA seeking to ban menthol cigarettes? 4 questions answered

The FDA has opened the public comment period for the agency’s proposed ban on menthol cigarettes. Epidemiology and global health professor Rafael Meza studies data modeling in disease prevention and cancer risk. David Mendez, who studies smoking cessation and tobacco control policies, is an associate professor of health management and…

The Conversation

Racism is different than colorism – here's how

Ronald Hall is a professor in the School of Social Work at Michigan State University. He has written over 200 books/articles/monographs, etc., on colorism – discrimination on the basis of skin tone, often among the same ethnic or racial group. Below are highlights from an interview with The Conversation. Answers…

The Conversation

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How Does Grupo Somar Acquisition Reaffirms Procaps' Strategy To Strengthen Footprint In LatAm

Integrated LatAm healthcare and pharmaceutical company Procaps Group (NASDAQ:PROC) has agreed to acquire Grupo Somar (including Grupo Farmacéutico Somar, Química y Farmacia, Gelcaps, and related entities) from Advent International, private equity. Deal terms were not disclosed. Grupo Somar is focused on developing, manufacturing, and marketing branded generic, private label, and OTC products targeted to…

Benzinga

US Lawmakers Reveal FDA Emergency Funds Bill To Tackle Baby Formula Shortage: Reuters

U.S. House Democrats unveiled a bill to provide $28 million in emergency funds to the FDA to help it respond to a shortage of infant formula and strengthen supervision. A House Appropriations Committee said that the funds would provide the FDA with the resources to prevent fraudulent products from being placed on…

Benzinga

How America feeds its young

The widespread use of baby formula across America has come under the spotlight as a national shortage has sparked an infant nutritional crisis.

Axios

Baby formula shortage puts spotlight on how America feeds its young

The widespread use of baby formula across America has come under the spotlight as a national shortage has sparked an infant nutritional crisis.

Axios

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Despite Congress’ efforts, it’ll take time to refill the baby bottles - Roll Call

Lawmakers are scrambling to end the formula shortage, but experts say it will be months before families will feel an impact.

Roll Call

As Red Cross moves to pricey blood treatment method, hospitals call for more choice

Americans generally don’t spend much time thinking about the nation’s blood supply.

Tribune News Service

A love letter to the perfect pasta shape

They bounce, they squeak, they whistle, they fling sauce in unpredictable directions — and I love it

Salon

With old-school technology, can Novavax win over COVID vaccine skeptics?

Since their debut just 18 months ago, three COVID-19 vaccines have saved an estimated 2.2 million American lives, changed the trajectory of a pandemic and inspired all manner of conspiracy theories.

Los Angeles Times

FDA Declines Emergency Use Request For An Antidepressant As COVID-19 Treatment

The FDA has decided not to authorize fluvoxamine, an antidepressant, to treat COVID-19. The agency that data has not shown the drug to be an effective therapeutic for fighting the virus. "Based on the review of available scientific evidence, the FDA has determined that the data are insufficient to conclude that fluvoxamine…

Benzinga

Sorrento Starts Mid-Stage Study Of Abivertinib In Prostate Cancer

The FDA has signed off Sorrento Therapeutics Inc's (NASDAQ:SRNE) investigational new drug application (IND) for Abivertinib (Fujovee) for Phase 2 MAVERICK study in metastatic castrate-resistant prostate cancer (mCRPC). The MAVERICK study will be conducted in a partnership with the Prostate Cancer Clinical Trials Consortium and will enroll participants with both abiraterone-naïve and abiraterone-progressing…

Benzinga

Why is there a baby formula shortage in the US?

With children hospitalised and parents paying up to $100 for a can, the president has now invoked a wartime measure to try to ensure there is enough formula to feed America’s babies

The Independent UK

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Axios

House Democrats release $28 million aid bill to address baby formula shortage

The money is intended to help the FDA prepare for potential future shortages.

WEKU

FDA authorizes first COVID booster for children ages 5 to 11

The Food and Drug Administration expanded authorization of Pfizer-BioNTech's COVID vaccine to enable kids ages 5 to 11 who were vaccinated at least five months ago to get a third shot.

Benzinga

FDA Gives Nod To First Nonprescription COVID-19 Test That Also Detects Flu, RSV

The FDA has authorized the first nonprescription test to detect Covid-19, influenza, and respiratory syncytial virus (RSV). The test, called the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test, was developed by Laboratory Corp of America Holdings (NYSE:LH). It can be sold directly to consumers online or at retail. A person can self-collect a nasal…

Benzinga

FDA May Authorize Pfizer-BioNTech's COVID-19 Booster For 5-11 Year Kids Soon: NYT

The FDA is expected to authorize a booster shot of Pfizer Inc (NYSE:PFE) / BioNTech SE's (NASDAQ:BNTX) COVID-19 vaccine for children aged 5 to 11 probably by today, the New York Times reported, citing people familiar with the matter. The companies submitted an application to the FDA for authorization last month. They have cited data from…

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Benzinga

Applied Genetic's Vision Loss Gene Therapy Shows Encouraging Safety, Efficacy At Three Months

Applied Genetic Technologies Corp (NASDAQ:AGTC) reported three-month interim data from its ongoing Phase 2 Skyline trial of AGTC-501 for X-linked retinitis pigmentosa (XLRP), an inherited condition causing progressive vision loss in boys and young men. AGTC-501 is a recombinant AAV viral vector-based gene therapy targeting mutations in the RPGR gene. There were robust…

Benzinga

'Mother Like' Kim Jong-Un Personally Tastes Baby Formula To Ensure Quality: North Korea Mocks US Shortages

Taking a dig at the U.S. formula shortages, a bizarre news article from North Korean state media randomly claimed that Kim Jong Un personally oversaw the perfection of the nation's baby formula recipe.

Benzinga

73 Biggest Movers From Yesterday

Gainers AgriFORCE Growing Systems Ltd. (NASDAQ: AGRI) shares jumped 65.9% to close at $2.77 on Monday after gaining around 10% on Friday.

Benzinga

US Baby Formula Crisis Could See Some Relief As FDA, Abbott Agree On Deal

The baby formula shortage that has morphed into a crisis in the U.S. could soon see some relief following an agreement between market leader Abbott Laboratories (NYSE: ABT) and the Food and Drug Administration.

WEKU

FDA announces plans to ease the shortage of baby formula

Abbott, one of the largest formula-makers in the U.S., has reached an agreement with the government to bring a closed factory back on line. And the FDA is easing some restrictions on imported formula.

The Independent UK

Abbott Nutrition strikes deal with FDA to restart factory linked to baby formula shortage

Shelves across US now empty of essential product

Chicago Sun-Times

Deal reached to reopen baby formula plant, Abbott says

The company, headquartered in Chicago, did not immediately detail terms of the agreement with the Food and Drug Administration, which has been investigating safety concerns at the firm’s Sturgis, Michigan, plant.

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