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The Latest Breaking News from US Food and Drug Administration

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

US Stock Futures Rise After Recording Worst Sell-Off Since June 2020; PPI Data In Focus

Pre-open movers U.S. stock futures traded higher in early pre-market trade on Wednesday after recording sharp losses on Tuesday following the release of inflation data for August. All the three major indices settled sharply lower, notching their biggest single-session percentage declines since June 2020.

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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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

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

Important Biotech Catalysts For September 7, 2022 - End Of The Day Summary

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Pfizer’s (NYSE:PFE) lead drug GBS6 or PF-06760805 for the prevention of invasive GBS disease due to the vaccine serotypes in newborns and young infants by active immunization of their mothers during pregnancy. Pfizer shares traded in a…

Benzinga

Recap Of Tuesday's Biotech Catalysts - End Of the Day Summary

Amgen (NASDAQ:AMGN) announced top-line results from the global Phase 3 CodeBreaK 200 trial evaluating once daily oral LUMAKRAS (sotorasib) in patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC), the study met primary endpoint. Amgen shares traded in a range of $238.29 to $240.31 on day volume of 2.43 million shares, closed regular…

Benzinga

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2 Stocks That Are More Than COVID-19 Plays

While the COVID-19 pandemic benefitted Johnson & Johnson (JNJ) and Pfizer (PFE) significantly as their vaccines helped the world recover from the crisis, these stocks are more than just COVID-19 plays because of their strong product portfolio and pipeline. They are well-positioned to capitalize on the rising chronic diseases, an…

StockNews.com

Recap Of Thursday's Biotech Catalysts - End Of the Day Summary

Pfizer (NYSE:PFE) announced positive top-line data from the Phase 3 clinical trial RENOIR investigating its bivalent RSV prefusion F vaccine candidate, RSVpreF, when administered to adults 60 years of age or older. Pfizer, Inc. shares traded in a range of $47.27 to $47.95 on day volume of 14.45 million shares, closed…

Benzinga

Recap Of Wednesday's Biotech Catalysts - End Of the Day Summary

The European Commission (EC) has granted conditional marketing authorization (CMA) to BioMarin Pharmaceutical’s (NASDAQ:BMRN) lead asset ROCTAVIAN (valoctocogene roxaparvovec) gene therapy for the treatment of severe hemophilia A (congenital Factor VIII deficiency) in adult patients. BioMarin shares traded as high as 2.28 percent, in a range of $91.39 to $93.68…

Benzinga

Taking the pill may change your behaviour – but exactly how is still uncertain

The first hormonal contraceptive (the “pill”) was approved by the US Food and Drug Administration in 1960. Hormonal contraceptives have since become one of the most prescribed drugs in the world, used daily by more than 100 million people worldwide.

The Conversation

Pfizer files application for booster against latest variants

Pfizer Inc. and BioNTech SE asked the U.S. to authorize a new COVID-19 booster shot customized against the currently circulating COVID-19 variants as governments race to protect their populations against the ever-mutating virus.

Tribune News Service

Recap Of Monday's Biotech Catalysts - End Of the Day Summary

Gritstone bio (NASDAQ:GRTS) announced that interim results from the Phase 1/2 trial of GRANITE, its individualized, vaccine-based immunotherapy candidate for solid tumor cancers, were published today in Nature Medicine. The initial results from the study are expected during second half of 2023. Gritstone shares traded in a range of $3.96 to $4.24…

Benzinga

Recap of Tuesday's Biotech Catalysts - End Of the Day Summary

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Relmada Therapeutics’ (NASDAQ:RLMD) lead asset REL-1017 as a monotherapy for the treatment major depressive disorder (MDD). Relmada shares traded in a range of $26.02 to $27.96 on a day volume of 173.79 thousand shares, closed regular trading…

Benzinga

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Benzinga

Recap Of Thursday's Biotech Catalysts - End Of the Day Summary

The European Commission (EC) has approved AstraZeneca (NASDAQ: AZN) and Merck’s (NYSE: MRK) LYNPARZA as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline B

StockNews.com

3 Low-Volatility Stocks to Invest in Right Now

U.S. GDP declined for the second straight quarter from April to June, adding to the recession concerns. Moreover, considering the lingering macroeconomic headwinds, we think it could be wise to scoop up shares of low-volatility stocks Leidos (LDOS), Incyte (INCY), and The Coca-Cola Company (KO) now. Keep reading….

Benzinga

Recap Of Monday's Biotech Catalysts - End Of the Day Summary

The U.S. Food and Drug Administration (FDA) has cleared the Eledon Pharmaceuticals’ (NASDAQ:ELDN) Investigational New Drug (IND) application to evaluate Tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant. Eledon shares traded in a range of $2.89 to $3.16 on a day volume of 31.27 thousand…

Benzinga

Recap Of Friday's Biotech Catalysts - End of The Day Summary

The U.S. Food and Drug Administration (FDA) has approved Arcutis Biotherapeutics’ (NASDAQ:ARQT) New Drug Application (NDA) for ZORYVE (roflumilast) cream 0.3% for the treatment of plaque psoriasis in patients 12 years of age or older. The company expects commercial launch of the product in Mid-August. Arcutis shares traded in a range of…

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Los Angeles Times

What the heck is Pink Sauce and why should anyone not on TikTok care? Let us explain

You may have seen a “Pink Sauce” headline in your social feeds sometime in the past week. Maybe you skipped over it, but now it’s hard to escape. The Pink Sauce situation is real, and chef Carly Pii is taking it very, very personally.

Benzinga

Recap of Wednesday's Biotech Catalysts - End of The Day Summary

IDEAYA Biosciences (NASDAQ:IDYA) has entered into a clinical trial collaboration and supply agreement with Amgen Inc. to evaluate the efficacy and safety of IDE397 with Amgen's AMG 193 in a Phase 1 clinical trial. IDEAYA shares traded in a range of $14.59 to $15.82 on a day volume of 130.58…

Benzinga

Recap of Tuesday's Biotech Catalysts - End Of The Day Summary

The U.S. Food and Drug Administration (FDA) has granted tentative approval to Avadel Pharmaceuticals’ (NASDAQ: AVDL) lead candidate LUMRYZ (FT218) for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.

Benzinga

Recap of Monday's Biotech Catalysts - End of the Day Summary

Abbvie (NYSE: ABBV) has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for atogepant for the prophylaxis of migraine in adult patients who have at least four migraine days per month.

StockNews.com

This Biotech Stock Looks Like a Prime Growth Play

Diversified healthcare company Abbott (ABT) has demonstrated significant innovations across its segments, and given its dominant market position, the company’s prospects look bright. The stock could be a solid choice as it is well-positioned to survive short-term market fluctuations. Let’s discuss this in detail….

StockNews.com

4 "Strong Buy" Biotech Stocks to Add to Your Watchlist

As the Biotech industry’s role in finding cures for chronic diseases and critical conditions is expected to keep attracting investors’ attention, it could be wise to scoop up shares of the fundamentally-strong biotech companies Vertex Pharmaceuticals (VRTX), United Therapeutics (UTHR), Amgen (AMGN), and Sino Biopharmaceutical (SBHMY) because of their solid…

Benzinga

Recap of Tuesday's Biotech Catalysts - End of the Day Summary

Ionis (NASDAQ: IONS) announced that Eplontersen met co-primary and secondary endpoints in interim analysis of the Phase 3 NEURO-TTRansform study for hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) Ionis shares are trading low 4 percent at $35.10 in the after-hours session

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