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The Latest Breaking News from FDA

Important Biotech Catalysts For September 14, 2022 - End Of The Day Summary

The U.S. Food and Drug Administration (FDA) has granted fast track designation for the development of TRACON’s (NASDAQ:TCON) lead asset envafolimab (KN035) for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy. TRACON shares…

Benzinga

FDA issues urgent recall on Medtronic surgical tubes

The U.S. Food and Drug Administration has issued a Class I recall, the agency's most serious category, for certain tracheal tubes made by Medtronic.

Tribune News Service

New ALS drug funded by Ice Bucket Challenge already in use in South Florida trials

While the country awaits federal approval of a new ALS drug, people in South Florida with the disease already are using it.

Tribune News Service

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Is the new omicron vaccine worth it?

The omicron-specific booster vaccine hit the market — some wonder if it's worth getting

Salon

Commentary: Did the US jump the gun with the new omicron-targeted vaccines?

Last month, the FDA authorized omicron-specific vaccines, accompanied by breathless science-by-press release and a media blitz. Just days after the FDA’s move, the Centers for Disease Control and Prevention followed, recommending updated boosters for anyone age 12 and up who had received at least two doses of the original COVID-19…

Tribune News Service

Why Comera Life Sciences Shares Jumped 101%; Here Are 74 Biggest Movers From Yesterday

Gainers Akero Therapeutics, Inc. (NASDAQ: AKRO) shares jumped 136.8% to settle at $29.05 on Tuesday after the company's Phase 2b HARMONY study met its primary endpoint for both the 50mg and 28mg EFX dose groups.

Benzinga

Important Biotech Catalysts For September 13, 2022 - End Of The Day Summary

Akero Therapeutics (NASDAQ:AKRO) revealed topline data from HARMONY, a 24-week Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with pre-cirrhotic nonalcoholic steatohepatitis (NASH), the study met its primary endpoint for both the 50mg and 28mg EFX dose groups. Akero Therapeutics shares…

Benzinga

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5 “Strong Buy” Health Care Stocks to Buy This Week

Rising prevalence of chronic diseases and the increasing aging population are significant growth drivers of the healthcare industry. Moreover, growing investments in technological advancements should bode well for the industry. Thus, we think investing in quality healthcare stocks Johnson & Johnson (JNJ), Pfizer (PFE), Novo Nordisk (NVO), Bristol-Myers Squibb (BMY),…

StockNews.com

Affordability questions linger around over-the-counter birth control

"There is no single magic bullet to solving all problems with access and affordability issues."

Axios

3 Health Care Stock Under $50 You Can Buy Today

The healthcare industry is anticipated to grow significantly in the coming years, thanks to strong demand amid rising chronic diseases, technological advancements, and rising healthcare spending. Therefore, we think fundamentally sound healthcare companies Pfizer (PFE), GSK Plc (GSK), and Teva Pharmaceutical (TEVA), which are currently trading under $50, could be…

StockNews.com

ATE.TO: Plans on Track for Acute Pain Program for Otenaproxesul…

By David Bautz, PhD OTC:ATBPF | TSX:ATE.TO READ THE FULL ATE.TO RESEARCH REPORT

Benzinga

Covid-19 boosters: Immunologists answer 5 key questions about the new shots

What is different about the updated booster shots? Two scientists offer their expertise to answer five questions about the shots.

Inverse

Important Biotech Catalysts For September 9, 2022 - End Of The Day Summary

The U.S. Food and Drug Administration (FDA) has approved Spectrum Pharmaceuticals’ (NASDAQ:SPPI) lead asset ROLVEDON (eflapegrastim-xnst) injection to decrease the incidence of infection, as manifested by febrile neutropenia. Spectrum Pharmaceuticals shares traded as high as 3.17 percent, in a range of $1.21 to $1.30 on day volume of 6.8 million…

Benzinga

Juul just lost a big battle

The e-cigarette company was being investigated by more than 30 states for allegedly marketing its products to youth

Salon

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StockNews.com

3 Dividend Stocks You Can Buy and Hold for Years to Come

The stock market has witnessed significant volatility on worries over a slowing economy amid high inflation and the Fed’s hawkish stance to tame it. As these factors are expected to keep the market under pressure in the near term, it could be wise to invest in fundamentally strong dividend-paying stocks…

Los Angeles Times

Michael Hiltzik: This life-saving drug will cost a record $2.8 million. Who will pay the price?

For the estimated 1,500 Americans suffering from a blood disorder known as beta thalassemia, the Food and Drug Administration's approval Aug. 17 of the drug Zynteglo was almost unalloyed good news.

Benzinga

Anebulo Pharma Posts FY 2022 Earnings, Positive Results From Clinical Trial For Treatment Of Acute Cannabinoid Intoxication

Anebulo Pharmaceuticals, Inc. (NASDAQ: ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance abuse, released its financial results for the three months and twelve months ended June 30, 2022.

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

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Benzinga

Top Financial Stories Friday, September 09: Elon Musk Hints At Potential Apple-SpaceX Partnership, GM's EV For Cost Conscious Buyers, Google Under DOJ Scanner For Search-Engine Dominance And More...

Bloomberg When The Bank Error Is Not In Your Favor: Pay Back $500 Million

Axios

Superbugs are a "second punch" after pandemic

There was a 15% rise in drug-resistant infections in hospitalized patients from 2019 to 2020.

Benzinga

Why ShiftPixy Surged Around 177%; Here Are 71 Biggest Movers From Yesterday

Gainers ShiftPixy, Inc. (NASDAQ: PIXY) shares surged 176.5% to close at $31.00 on Thursday after the company announced plans to spin-off ShiftPixy Labs and dividend its digital securities to shareholders.

The Independent UK

Breast implants may be linked to more cancers than previously thought, FDA warns

‘This is an emerging issue and our understanding is evolving,’ FDA says

Benzinga

Trump Ally Dr. Oz Hyped Unapproved 'Covid Cures' From Companies He Owns Shares Of

Republican Pennsylvania Senate candidate Dr. Mehmet Oz owns shares of two companies he publicly supported, touting their drugs as potential Covid-19 treatments — even though the drugs weren't approved by the U.S. Food and Drug Administration (FDA).

Benzinga

Why IMARA Jumped Around 75%; Here Are 54 Biggest Movers From Yesterday

Gainers

Tribune News Service

Controversial ALS drug from Amylyx gets rare second FDA meeting

Amylyx Pharmaceuticals Inc.’s controversial treatment for amyotrophic lateral sclerosis won the support of a panel of U.S. regulatory advisers, putting the product on track for likely clearance.

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