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The Latest Breaking News from FDA

Major Depressive Disorder Could Soon Have Treatment Option Via Cybin's Psilocybin Analog

Cybin Inc. (CYBN), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics," has submitted an Investigational New Drug (or “IND”) application to the FDA.

Benzinga

Attention Biotech Investors: Mark Your Calendar For These June PDUFA Dates

May turned out to be a month of mixed fortunes as far as regulatory reviews are concerned. New molecular entity approvals, an indicator of innovation in drug research, totaled three during the month, bringing the total for the year to 15. This compares to the 24 NMEs the Food and…

Benzinga

Hepatitis A Outbreak Linked To Organic Strawberries: What You Need To Know

The U.S. and Canadian governments have traced recent outbreaks of hepatitis A infections to organic strawberries sold at major supermarket chains.

Benzinga

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FDA Accepts Regeneron, Sanofi's Filing For Review In Skin Disease

The U.S.

Benzinga

Delta-8 Cannabis Compound Is Legal, Says Federal Appeals Court

Plus: Libertarian Party changes abortion and bigotry planks, the FDA's weird rejection of fluvoxamine for treating COVID-19, and more...

Reason

5 Oncology Stocks Wall Street Predicts Will Rally 135% or More

The oncology industry is expected to grow considerably in 2022, driven by the rising occurrence of cancer in the U.S. population. Furthermore, increasing investments by biopharmaceutical companies and the government should fuel the industry's growth. Given the industry's bright growth prospects, Wall Street analysts expect the stocks of quality oncology…

StockNews.com

Hepatitis A outbreak in the US, Canada: What we know so far

The virus is likely to have spread due to contaminated organic strawberries sold between March 5 and April 25.

Al Jazeera

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FDA’s plan to ban menthol cigarettes is overdue

Other countries, including Canada and countries in the European Union, have already taken this potentially live-saving step to take a more addictive product off the market.

Chicago Sun-Times

US, Canadian regulators tie hepatitis cases to strawberries

U.S. and Canadian regulators are investigating a hepatitis outbreak that may be linked to fresh organic strawberries

The Independent UK

The FDA is investigating a hepatitis A outbreak potentially linked to strawberries

The FDA is investigating a hepatitis A outbreak potentially linked to strawberries sold at a number of retailers, including Trader Joe's, Kroger, Safeway, Aldi and Walmart.

WEKU

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

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

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WEKU

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.

The Independent UK

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’

Benzinga

NOVN: First EPI Sales

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

Benzinga

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.

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The Independent UK

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

Social media users shared a range of false claims this week

Benzinga

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.

Reason

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...

Benzinga

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

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.

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