Biotech - Spark Newswire

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Amgen’s First KRAS-Targeted Therapy, Lumakras Scores FDA Approval For Lung Cancer

Today, 1:28 PM

The FDA has given accelerated approval to Amgen Inc’s (NASDAQ:AMGN) Lumakras (sotorasib) for non-small cell lung cancer (NSCLC) patients harboring kras mutation.…

AMGN

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FDA
News

Amgen Press Release Confirms FDA Approved LUMAKRAS For Patients With KRAS G12C-Mutated Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

By Benzinga Newsdesk

Today, 1:28 PM

Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved LUMAKRAS™ (sotorasib) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic

AMGN

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European Drug Regulator Supports Use Of Pfizer-BioNTech COVID-19 Vaccine In Adolescents: Reuters

By Vandana Singh

Today, 1:28 PM

European Medical Agency backed the use of Pfizer Inc (NYSE:PFE) – BioNTech SE’s (NASDAQ:BNTX) COVID-19 vaccine for children as young as 12,…

BNTX

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FDA
News

Amgen Receives FDA Approval for Lumakras

By Charles Gross

Today, 1:28 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, 1:28 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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FDA Advisory Committee Votes In Favor Of Approval Of Provention Bio’s Diabetes Med

By Vandana Singh

Today, 1:28 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, 1:28 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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Cyclerion Therapeutics Highlights Publication Of CY6463 Preclinical Data In Frontiers In Pharmacology

By Bill Haddad

Today, 1:28 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