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Janssen submits New Drug Application to FDA for Apalutamide (ARN-509)

Oct 11, 2017
Janssen Biotech announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for apalutamide, an investigational, next generation oral…
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Moffitt Researchers Discover New Targets for Approved Cancer Drug

Oct 11, 2017
Developing new drugs to treat cancer can be a painstaking process taking over a decade from start to Food and Drug Administration approval. Scientists are trying to develop innovative…
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Kaleido Biosciences & CoreBiome Partner to Accelerate Microbiome Therapeutic Development

Oct 10, 2017
Kaleido Biosciences announced an agreement with CoreBiome, a genomics platform company focused on accelerating microbiome innovation with expert genomics and big-data analytics, to…
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Boston Biomedical Announces Orphan Drug Designation by FDA for DSP-7888

Oct 10, 2017
Boston Biomedical announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for DSP-7888, an investigational cancer peptide vaccine, for the…
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AbbVie & Turnstone announces collaboration on Viral Immunotherapies in Oncology

Oct 10, 2017
AbbVie announced a research, option and license agreement whereby AbbVie obtained an exclusive option to license up to three of Turnstone's next-generation oncolytic viral…
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Astellas Pharma and Seattle Genetics Initiate Pivotal Trial of Enfortumab Vedotin

Oct 10, 2017
Astellas Pharma and Seattle Genetics announced dosing of the first patient in EV-201, a registrational phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or…
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FDA accepts Allergan’s new drug application for Ulipristal Acetate for Uterine Fibroids

Oct 10, 2017
Allergan announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ulipristal acetate, an investigational drug for the treatment…
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FDA grants Breakthrough Therapy Designation to Ansun’s Experimental Drug DAS181

Oct 10, 2017
Ansun BioPharma announced that the Division of Antiviral Products of the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Ansun's first-in-class…
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FDA grants Priority Review to Gilotrif for uncommon EGFR mutations in advanced NSCLC

Oct 10, 2017
Boehringer Ingelheim announced that the supplemental New Drug Application (sNDA) for Gilotrif® (afatinib) has been accepted for filing and granted Priority Review by the U.S. Food and…
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EMA accepts Marketing application for Imfinzi to treat NSCLC patients

Oct 10, 2017
AstraZeneca, along with MedImmune, its global biologics research and development arm, has announced that the European Medicines Agency (EMA) has accepted a Marketing…
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