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The Latest Breaking News from FDA

Australia, New Zealand Express Support To Address USA Baby Food Crisis

Australia is in talks with the U.S. to supply baby food, Reuters reports.

Benzinga

18 Stocks Moving in Wednesday's Pre-Market Session

Gainers Endo International plc (NASDAQ: ENDP) rose 46.1% to $0.7710 in pre-market trading after gaining over 12% on Tuesday.

Benzinga

77 Biggest Movers From Yesterday

Gainers TherapeuticsMD, Inc. (NASDAQ: TXMD) shares climbed 364% to close at $9.93 on Tuesday after the company announced it has entered into a definitive merger agreement to be acquired by an affiliate of EW Healthcare Partners.

Benzinga

From analysis to the latest developments in health,
read the most diverse news in one place.

FDA launching website, app for registration of cannabis, hemp cultivation

The Food and Drug Administration is launching a phone app and a website for people to register their cultivation of cannabis and hemp plants, which are being removed from the category 5 narcotics list, FDA deputy secretary-general Withid Sariddeechaikool said on Wednesday.

Bangkok Post

Zero Cost, FDA CGMP Approved LSD For Qualified Researchers, Provided By Ceruvia Lifesciences

Ceruvia Lifesciences, a biopharmaceutical company, announced that it has produced the world's first LSD that meets stringent "Current Good Manufacturing Practices" (CGMP) standards required by the FDA for new drug approvals and is offering to supply it at no cost to qualified researchers.

Benzinga

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

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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

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

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

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WEKU

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.

Reason

There's No Political Solution to the Baby Formula Shortage

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

Tribune News Service

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.

The Independent UK

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

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news in one place.

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The Guardian - AU

Australian company to ship baby formula to shortage-hit US

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

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.

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.

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