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Tagrisso

AstraZeneca Pharma India files writ petition in Delhi High Court against NPPA demand notice

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.

July 1, 2021 by expresspharma

EU clears Tagrisso for early-stage EGFR-mutated lung cancer

AstraZeneca Tagrisso EU NSCLC

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.

June 1, 2021 by pharmatimes

AZ' Tagrisso first to win MHRA approval under Project Orbis

Orbis AstraZeneca MHRA Tagrisso

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.

May 8, 2021 by pharmatimes

Tagrisso moves closer towards EU approval for early-stage lung cancer

Tagrisso lung cancer EMA CHMP NSCLC

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.

April 29, 2021 by pharmatimes

FDA Approves First Adjuvant Therapy for Most Common Type of Lung Cancer

FDA Tagrisso lung cancer adjuvant therapy

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.

December 23, 2020 by americanpharmaceuticalreview

Green light for AZ’s Tagrisso in early-stage lung cancer

Tagrisso lung cancer NSCLC FDA AstraZeneca

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).

December 22, 2020 by pharmatimes

AZ’s Tagrisso scores priority review from FDA

Tagrisso AstraZeneca lung cancer NSCLC

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.

October 22, 2020 by pharmatimes

NICE backing for AZ' Tagrisso

Tagrisso NICE EGFR NSCLC AstraZeneca

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) ...

September 15, 2020 by pharmatimes

Daiichi Sankyo, AstraZeneca collaborate to evaluate patritumab deruxtecan in combination with TAGRISSO in EGFR-mutated NSCLC

Daiichi Sankyo AstraZeneca patritumab deruxtecan NSCLC TAGRISSO

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) ...

August 11, 2020 by pharmaceutical-business-review

TAGRISSO granted FDA breakthrough therapy status in EGFR-mutated lung cancer

TAGRISSO FDA lung cancer

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...

August 5, 2020 by pharmaceutical-business-review

Tagrisso shows 'unprecedented' disease free survival in lung cancer

Tagrisso AstraZeneca EGFR lung cancer

According to AstraZeneca, its EGFR inhibitor Tagrisso (osimertinib) has shown 'unprecedented disease-free survival' in the adjuvant treatment of patients with EGFR-mutated lung cancer.

June 1, 2020 by pharmatimes

China grants Tagrisso (osimertinib) marketing authorisation

Tagrisso osimertinib china NSCLC

Following positive clinical trials, the Tagrisso drug has been given marketing authorisation in China for treatment of NSCLC.

September 6, 2019 by europeanpharmaceuticalreview