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Biotech

Biotech

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  • FDA
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Amgen Receives FDA Approval for Lumakras

By Charles Gross
Today, 6:11 PM
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214665

AMGN

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Humanigen Files US Emergency Use Application For Lenzilumab For COVID-19

By Vandana Singh
Today, 6:11 PM
Humanigen Inc (NASDAQ:HGEN) has submitted an application to the FDA seeking Emergency Use Authorization (EUA) for lenzilumab to treat patients hospitalized…

HGEN

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  • Biotech
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FDA Advisory Committee Votes In Favor Of Approval Of Provention Bio’s Diabetes Med

By Vandana Singh
Today, 6:11 PM
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 10-7 in favor of recommending ap

PRVB

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AstraZeneca Announced Tagrisso Approved in EU in Early Lung Cancer

By Charles Gross
Today, 6:11 PM
AstraZeneca's (NYSE: AZN) Tagrisso (osimertinib) has been approved in the European Union (EU) for the adjuvant treatment of adult patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent.

AZN

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  • Biotech
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Cyclerion Therapeutics Highlights Publication Of CY6463 Preclinical Data In Frontiers In Pharmacology

By Bill Haddad
Today, 6:11 PM
Cyclerion Therapeutics, Inc. (NASDAQ:CYCN) today announced the publication of preclinical data of CY6463 in Frontiers in Pharmacology. Cyclerion is developing CY6463, an oral, first-in-class, central nervous

CYCN

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Justice Department Opens Probe In Presumed lapses at Eli Lilly’s COVID-19 Drug Plant: Reuters

By Vandana Singh
Today, 6:11 PM
The U.S. Justice Department has launched a criminal investigation into Eli Lilly and Co (NYSE:LLY) focused on alleged manufacturing irregularities…

EBS

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  • FDA
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Myriad Genetics Submits sPMA for myChoice CDx with Zejula in First-Line Platinum Responsive Advanced Ovarian Cancer

By Charles Gross
Today, 6:11 PM
Myriad Genetics, Inc. (NASDAQ:MYGN) announced that it has submitted a supplementary premarket approval (sPMA) application to the U.S.…

MYGN

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  • Biotech
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Biohaven’s Verdiperstat Receives FDA ‘May Proceed’ Letter To Initiate Trial In Amyotrophic Lateral Sclerosis Conducted By The Healey Center For ALS At Mass General

By Benzinga Newsdesk
Today, 6:11 PM
Biohaven Pharmaceutical Holding Company Ltd. (NYSE:BHVN) (“Biohaven” or the “Company”), a biopharmaceutical company with multiple late-stage neuroscience drug…

BHVN

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Despite Bright Prospects, Credit Suisse Begins Thermo Fisher With Neutral Rating

By Priya Nigam
Today, 6:11 PM
Although Thermo Fisher Scientific Inc. (NYSE:TMO) seems well-positioned to generate robust organic revenue growth and healthy margin expansion…

TMO

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Neurotrope Rips 150% Higher On Improved Alzheimer’s Data, NIH Funding

By Shanthi Rexaline
Today, 6:11 PM
Shares of thinly-traded microcap biopharma Neurotrope Inc (NASDAQ:NTRP) gap-opened sharply higher on above 50 times average volume following…

NTRP

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