(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan has been accepted by the U.S. FDA for treating advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) in patients who have previously received systemic therapies. The … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged advanced NSCLC, antibody-drug conjugate, AstraZeneca, Biologics License Application, BLA, breakthrough therapy designation, Daiichi Sankyo, datopotamab deruxtecan, drug approval, EGFR-mutated, EGFR-tyrosine kinase inhibitors, FDA, metastatic NSCLC, non-small cell lung cancer, NSCLC, objective response rate, oncology, partnership, Phase III Trials, Priority Review, safety profile, systemic therapies, TROP2-directed, TROPION-Lung01, TROPION-Lung05, TROPION-Lung14, TROPION-Lung15
AstraZeneca’s first Breakthrough Therapy Designation for a respiratory medicine Designation based on Phase IIb PATHWAY data that demonstrated tezepelumab significantly reduced asthma exacerbations compared to placebo in severe asthma CAMBRIDGE, 12-Sep-2018 — /EuropaWire/ — AstraZeneca and its partner Amgen Inc. (Amgen) … Read the full press release
Posted in Healthcare, Pharma & Biotech
Tagged Amgen, asthma, AstraZeneca, breakthrough therapy designation, eosinophilic_phenotype, medicine, respiratory, Sean Bohen, tezepelumab
Second FDA Breakthrough Therapy Designation for MPDL3280A following bladder cancer in 2014 BASEL, 3-2-2015 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received a second Breakthrough Therapy Designation from the United States Food and … Read the full press release
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