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The Latest Breaking News from FDA

There's No Political Solution to the Baby Formula Shortage

Governments can't plan economies, but can disrupt them.

Reason

Novavax missed its global moonshot but is angling to win over mRNA defectors

Novavax hitched its wagon to the global coronavirus pandemic. Before most Americans truly grasped the scope of the danger, the small Maryland biotech startup had secured $1.6 billion in U.S. funding for its COVID-19 vaccine. Its moonshot goal: delivering 2 billion shots to the world by mid-2021.

Tribune News Service

Strawberries recalled from grocery stores across North America amid Hepatitis A outbreak

Around 17 people have been infected and 12 hospitalised in US, while Canada has recorded 10 infections and four hospitalisations

The Independent UK

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Australian company to ship baby formula to shortage-hit US

Joe Biden welcomes ‘good news’ as Bubs Australia increases production and reassures local customers

The Guardian - AU

More baby formula shipments arrive from overseas in an effort to ease the shortage

Australia is sending the equivalent of more than 27 million 8-ounce bottles of goat's milk and other baby formulas, as the U.S. government works to replenish store shelves during the shortage.

WEKU

Baby formula shortage will stretch on until late July, FDA chief says

‘My expectation is that within two months we should be beyond normal and with a plethora’

The Independent UK

NOVN: First EPI Sales

By John Vandermosten, CFA NASDAQ:NOVN READ THE FULL NOVN RESEARCH REPORT

Benzinga

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41 Stocks Moving In Friday's Mid-Day Session

Gainers Avadel Pharmaceuticals plc (NASDAQ: AVDL) shares rose 60.2% to $1.7136. Avadel Pharmaceuticals shares dipped 68% on Thursday after announcing new FDA request for experimental narcolepsy drug.

Benzinga

NOT REAL NEWS: A look at what didn't happen this week

Social media users shared a range of false claims this week

The Independent UK

Revive Therapeutics: Positive Comments From The FDA Regarding Primary Endpoint Change

The outlook for Revive Therapeutics Ltd. (OTC: RVVTF) Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine to treat COVID-19 got a little brighter on Thursday.

Benzinga

The FDA Completely Botched Its Response to the Baby Formula Shortage

Plus: Resurrecting an extinct tiger, reviewing the police response to the Uvalde shooting, and more...

Reason

FDA Battles Over CBD Hype Yet Again, This Time Warns Businesses Selling Illegal CBD For Food-Producing Animals

The Food and Drug Administration (FDA) sent letters to four CBD companies warning them against selling unauthorized CBD products for use in food-producing animals. Companies being warned are Haniel Concepts (doing business as Free State Oils), Hope Botanicals, Plantacea LLC (doing business as Kahm CBD

Benzinga

Abortion Pills - The Next Battleground In USA

The United States Supreme Court has not yet released its judgment, limiting abortion rights significantly.

Benzinga

88 Biggest Movers From Yesterday

Gainers Creatd, Inc. (NASDAQ: CRTD) shares jumped 58.5% to close at $1.28 on Thursday. Creatd’s board approved a rights offering of up to $40 million for 20 million shares at $2 per unit.

Benzinga

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news in one place.

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Benzinga

Mid-Afternoon Market Update: Dow Surges 575 Points; Apyx Medical Shares Spike Higher

U.S. stocks traded higher toward the end of trading, with the Dow Jones gaining 575 points on Thursday.

Benzinga

High Hopes For Alcohol Use Disorder Treatment: Clearmind's Successful Pre-IND Meeting With The FDA

The meeting, which took place on May 18 between the psychedelic pharmaceutical biotech company Clearmind Medicine Inc. (CMNDF) and the US Food and Drug Administration marks the completion the pre-IND New Drug Application stage.

Benzinga

Apyx Medical Stock Gains Following FDA Clearance of Renuvion Dermal Handpiece for Wrinkle Reduction

The U.S. Food and Drug Administration (FDA) announced 510(k) clearance (pre-market notification) of Apyx Medical’s (NASDAQ: APYX) Renuvion Dermal Handpiece for specific dermal resurfacing procedures.

Benzinga

Why Apyx Medical Shares Are Trading Higher Today?

Apyx Medical Corporation (NASDAQ:APYX) has FDA received 510(k) clearance for the use of the Renuvion Dermal Handpiece for specific dermal resurfacing procedures. The Renuvion Dermal Handpiece is indicated for dermatological procedures to treat moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II, or III. The company expects…

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news in one place.

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One news app.

Benzinga

Mid-Day Market Update: Crude Oil Jumps Over 3%; NRx Pharmaceuticals Shares Tumble

U.S. stocks traded higher midway through trading, with the Dow Jones gaining around 1.5% on Thursday.

WEKU

The Jif peanut butter recall is pulling a cascade of other products from store shelves

Many other companies use the peanut butter — the cause of a salmonella outbreak — and now they have recalls of their own. The FDA says the products made it to at least 10 other countries.

Benzinga

61 Stocks Moving In Thursday's Mid-Day Session

Benzinga

Lawmakers Seek Answers From FDA, Abbott On Nationwide Baby Formula Shortage

FDA officials appeared before a congressional panel to answer questions about the crisis after Abbott Laboratories (NYSE: ABT) recalled some baby formula products and closed its manufacturing plant in Sturgis, Michigan.

Benzinga

Mid-Morning Market Update: Markets Open Higher; US Economy Contracts 1.5% In Q1

U.S. stocks traded higher this morning, with the Nasdaq Composite gaining around 200 points on Thursday.

Benzinga

Pharma Stock Shoots Up As FDA Accepts NDA For Neuromuscular Disorder Drug Under Priority Review

Reata Pharmaceuticals (NASDAQ: RETA) announced that the U.S. Food and Drug Administration has accepted New Drug Application (NDA) for its lead drug candidate omaveloxolone for the treatment of patients with Friedreich's ataxia.

Benzinga

Pfizer's Combo Therapy For Fatty Liver Disease Gets FDA Fast Track Status

The U.S. Food and Drug Administration has granted Fast Track designation to Pfizer’s (NYSE: PFE) Ervogastat/Clesacostat Combination therapy for the treatment of Non-Alcoholic Steatohepatitis (NASH).

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