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AstraZeneca, Amgen asthma drug tezepelumab secures FDA breakthrough designation

UK biopharma company AstraZeneca and Amgen have secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for their asthma drug tezepelumab. The FDA breakthrough therapy designation for tezepelumab is for the treatment of patients with severe asthma, without an eosinophilic phenotype, who are administered inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids […]

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CHMP recommends AstraZeneca lung cancer drug Imfinzi EMA approval

Update on Imfinzi EMA approval : The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the approval of AstraZeneca lung cancer drug Imfinzi (durvalumab) for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC). The committee has recommended Imfinzi EMA approval of […]

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Acalabrutinib wins US FDA approval for mantle cell lymphoma treatment

Acalabrutinib FDA approval : AstraZeneca has secured an early approval for its blood cancer drug Calquence (acalabrutinib) for the treatment of mantle cell lymphoma in adult patients who were subjected to a minimum of one prior therapy for the rare type of blood cancer. According to the National Cancer Institute at the National Institutes of […]

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AstraZeneca lung cancer drug Tagrisso gets FDA breakthrough therapy designation

Pharma news updates : Tagrisso (osimertinib), the AstraZeneca lung cancer drug has bagged the breakthrough therapy designation (BTD) from the US FDA for the treatment of non-small cell lung cancer (NSCLC) in a first line setting. The BTD designation for the AstraZeneca cancer drug is specifically for treating metastatic NSCLC patients who have tested positive […]

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Astrazeneca ovarian cancer drug Lynparza shown to improve survival chances

Pharma giant AstraZeneca has reported that its ovarian cancer drug Lynparza (olaparib) as a maintenance therapy has considerably improved the survival chances of patients with germline BRCA-mutations (gBRCA) who had a relapse of the disease, who did not respond to platinum-based chemo. Phase 3 Trial of Astrazeneca Ovarian Cancer Drug Lynparza The observation of the […]

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AstraZeneca, Sanofi form R&D alliance for infant respiratory drug

AstraZeneca’s MedImmune and Sanofi Pasteur have formed a research and development alliance for a new infant respiratory drug, MEDI8897 which they are planning to commercialize after getting through the clinical trials and the necessary regulatory approvals. While MedImmune is the global biotech arm of British-Swedish pharma giant, Sanofi Pasteur is the vaccines division of French […]

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