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The Latest Breaking News from FDA

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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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.

Axios

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.

WEKU

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…

Benzinga

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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.

Benzinga

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.

WEKU

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

Shelves across US now empty of essential product

The Independent UK

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.

Chicago Sun-Times

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Chicago Tribune

Abbott enters into agreement with FDA, outlining terms for resuming infant formula production at Michigan site

CHICAGO — Abbott Laboratories and the U.S. Food and Drug Administration have come to an agreement on the steps the company needs to take before it can restart production of infant formula at a Michigan facility, Abbott said Monday.

Benzinga

Abbott Spent $5B On Stock Buybacks Instead Of Fixing Its Baby Formula Factory

The fear of not knowing where your child’s next meal comes from is something that no parent should face. But, because of a recall of Abbott Laboratories’ (NYSE: ABT) Similac and other popular baby formula brands, stores throughout the nation are limiting how much formula parents can buy.

StockNews.com

3 Healthcare Stocks That Pay Dominant Dividends

Despite heightened market volatility, the healthcare industry is expected to grow significantly in 2022 amid surging chronic diseases worldwide, an aging population, increasing healthcare expenditure, and numerous medical advancements. So, we think it could be wise to invest in fundamentally sound healthcare stocks Gilead (GILD), Takeda (TAK), and GlaxoSmithKline (GSK).…

Benzinga

Why Are Akebia Therapeutics Shares Falling Today?

Akebia Therapeutics Inc (NASDAQ:AKBA) and Otsuka Holdings (OTC: OTSKY) separately announced to call for licensing and co-development agreement for vadadustat. Otsuka sent a written notice to Akebia on May 12 that the partnership had been terminated. Akebia said in an SEC filing filed Friday that the termination will go into effect in a year.…

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Benzinga

Sanofi Says Sarclisa Shows 'Unprecedented Median Progression-Free Survival' In Multiple Myeloma Patients

Sanofi SA (NASDAQ:SNY) shared the latest results from the Phase 3 IKEMA trial evaluating Sarclisa (isatuximab) in patients with relapsed multiple myeloma receiving a proteasome inhibitor therapy. Sarclisa combined with carfilzomib and dexamethasone (Kd) demonstrated a median progression-free survival (mPFS) of 35.7 months, compared to 19.2 months in patients treated with Kd alone. …

Benzinga

FDA Warns About THC Copycat Edibles, Children In Serious Danger

About a month after a study led by researchers at NYU School of Global Public Health, revealed that “copycat” edibles can have levels of tetrahydrocannabinol or THC “that

Tribune News Service

FDA chief says shuttered baby formula plant could reopen soon, offering hope to ease shortage

The head of the Food and Drug Administration said Monday that a shuttered baby formula factory should reopen within two weeks, potentially easing a serious nationwide shortage.

Benzinga

Magenta Therapeutics Reveals Encouraging Interim Data From Lowest Dose Of MGTA-117 In Leukemia Trial

Magenta Therapeutics Inc (NASDAQ:MGTA) shared preliminary data from the Phase 1/2 dose-escalation trial of MGTA-117 in relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome with excess blasts. The data comes from a Cohort 1, evaluating the lowest dose of MGTA-117 (0.02 mg/kg). Three patients completed the safety evaluation period. A fourth patient with…

Benzinga

41 Stocks Moving In Monday's Mid-Day Session

Gainers Data Storage Corporation (NASDAQ: DTST) shares jumped 51.1% to $3.4750 after the company reported better-than-expected Q1 financial results.

Benzinga

scPharmaceuticals Shares Are Trading High Following FDA's Acceptance of NDA for FUROSCIX

scPharmaceuticals Inc. (NASDAQ: SCPH) announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) of the drug candidate FUROSCIX, for the treatment of congestion in patients with worsening heart failure.

Benzinga

FDA Accepts Travere Therapeutics' NDA for Sparsentan with Priority Review

The U.S. Food and Drug Administration (FDA) has accepted Travere Therapeutics’ (NASDAQ: TVTX) New Drug Application (NDA) under Subpart H and granted Priority Review of sparsentan for the treatment of IgA nephropathy (IgAN).

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