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AstraZeneca Pharma India files writ petition in Delhi High Court against NPPA demand notice
expresspharma
July 01, 2021
The notice of demand alleges that the company has overcharged about Rs 157.38 crore from March 8, 2019 to January 31, 2021, for Tagrisso (Osimertinib) 80 mg tablets.
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EU clears Tagrisso for early-stage EGFR-mutated lung cancer
pharmatimes
June 01, 2021
The European Commission (EC) has approved AstraZeneca’s (AZ) Tagrisso for the adjuvant treatment of early-stage, epidermal growth factor receptor mutated (EGFR) non-small cell lung cancer (NSCLC) following surgery.
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AZ' Tagrisso first to win MHRA approval under Project Orbis
pharmatimes
May 08, 2021
AstraZeneca's Tagrisso (osimertinib), a post-surgery treatment for lung cancer, is the first drug to receive approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Project Orbis.
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Tagrisso moves closer towards EU approval for early-stage lung cancer
pharmatimes
April 29, 2021
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended AstraZeneca’s (AZ) Tagrisso for approval in the EU for the treatment of early-stage lung cancer patients.
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FDA Approves First Adjuvant Therapy for Most Common Type of Lung Cancer
americanpharmaceuticalreview
December 23, 2020
The U.S. Food and Drug Administration (FDA) approved Tagrisso (osimertinib) as the first adjuvant treatment for patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation.
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Green light for AZ’s Tagrisso in early-stage lung cancer
pharmatimes
December 22, 2020
The US Food and Drug Administration (FDA) has approved AstraZeneca’s Tagrisso (osimertinib) for the treatment of adult patient with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
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AZ’s Tagrisso scores priority review from FDA
pharmatimes
October 22, 2020
AstraZeneca’s EGFR-tyrosine kinase inhibitor Tagrisso has been granted a priority review by the US Food and Drug Administration (FDA) for the treatment of early-stage EGFR-mutated lung cancer.
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NICE backing for AZ' Tagrisso
pharmatimes
September 15, 2020
AstraZeneca's Tagrisso (osimertinib) has been recommended for use within NHS England, in line with its licensed indication, for adults with untreated locally-advanced or metastatic epidermal growth factor receptor (EGFR) ...
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Daiichi Sankyo, AstraZeneca collaborate to evaluate patritumab deruxtecan in combination with TAGRISSO in EGFR-mutated NSCLC
pharmaceutical-business-review
August 11, 2020
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that it has entered into a clinical trial collaboration with AstraZeneca (LSE/STO/NYSE: AZN) to evaluate the combination of patritumab deruxtecan (U3-1402) ...
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TAGRISSO granted FDA breakthrough therapy status in EGFR-mutated lung cancer
pharmaceutical-business-review
August 05, 2020
AstraZeneca’s TAGRISSO (osimertinib) has been granted Breakthrough Therapy Designation (BTD) in the US for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer...