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FDA Grants Priority Review to New Biologics License Application for V116 Against Pneumococcal Disease

If approved, V116 would offer significant improvements in safety and effectiveness for the prevention of pneumococcal disease.

Eliav barrMerck sharp dohmeMerck research laboratoriesPrescription drug user fee actionPneumococcal vaccine naMerck sharpWorld vaccine congress west coast

Tarlatamab Application for SCLC Granted Priority Review by FDA

The treatment developed by Amgen could be the first therapeutic option approved for third-line treatment of advanced small cell lung cancer (SCLC).

Davidm reesePrescription drug user fee actionNew england journalBreakthrough therapy designationReal time oncology reviewProject orbisLung cancer

FDA Grants Priority Review to Amgen s Tarlatamab Application for Advanced Small Cell Lung Cancer

/PRNewswire/ Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Company s.

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New Drug Application for Treatment of Non-Small Cell Lung Cancer

New Drug Application for Treatment of Non-Small Cell Lung Cancer
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Charles baumDrug administrationThoracic oncology at dana farber cancer instituteLowe centerMirati therapeutics incMirati therapeuticsNew drug applicationPrescription drug user fee actionAccelerated approvalTime oncology reviewBreakthrough therapy designationThoracic oncologyDana farber cancer institute

FDA Grants Priority Review to Amgen s Tarlatamab Application for Advanced Small Cell Lung Cancer

FDA Grants Priority Review to Amgen s Tarlatamab Application for Advanced Small Cell Lung Cancer
marketscreener.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from marketscreener.com Daily Mail and Mail on Sunday newspapers.

Puerto ricoUnited statesJustin claeysDavidm reeseJessica akopyanTeneobio incKyowa kirin co ltdWorld best companiesChemocentryx incWorld health organizationDrug administrationOncology centerExchange commissionBeigene ltdAmerican cancer societyEuropean society for medical oncology

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