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Arrowhead Pharmaceuticals seeks Orphan Drug Designation for ARO-AAT

Feb 16, 2018
Arrowhead Pharmaceuticals seeks FDA's orphan drug designation to ARO-AAT.  Arrowhead’s second-generation investigational medicine for the treatment of a rare genetic liver disease…
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Banyan Biomarkers attained FDA’s De Novo request for Banyan BTI

Feb 16, 2018
Banyan Biomarkers asserted that the U.S FDA has extended De Novo request for the commercialization of Banyan BTI Brain Trauma Indicator), an in vitro diagnostic blood test to aid in the…
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Celgene Corporation asserted OTEZLA’s Phase II Clinical Trial data

Feb 16, 2018
Celgene Corporation asserted that data from a randomized, placebo-controlled, multi-center, phase II clinical trial of apremilast in patients with active ulcerative colitis who had…
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Arterys sought FDA clearance for Oncology AI suite

Feb 16, 2018
Arterys Inc declared its fifth 510 (k) clearance for Arterys Oncology AI suite and is milestone indicative of the company's momentum in applying AI to further medical imaging accuracy…
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Viz.ai sought De Novo FDA clearance for LVO strokes in CTA imaging

Feb 16, 2018
Applied artificial intelligence healthcare company, Viz.ai asserted that the US FDA has extended a De Novo request for the first-ever Computer -Aided Triage and Notification Platform to…
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DreaMed Diabetics attained CE Mark for Platform tackling Type 1 diabetes

Feb 16, 2018
DreaMed Diabetes asserted that it received CE Mark for the Advisor Pro decision-support platform for assisting healthcare professionals in the management of Type 1 diabetes. DreaMed…
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Evofem Biosciences completes enrollment in Phase 3 Clinical Trial for Amphora 

Feb 16, 2018
Evofem Biosciences aiming to meet women's unmet healthcare needs asserted completion of enrollment in its Phase 3 Clinical Trial evaluating Amphora vaginal gel for the prevention of…
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Citius enrolls first patient in Mino-Lok Phase 3 Clinical trial

Feb 16, 2018
Citius Pharmaceuticals emphasizing on adjunctive cancer care and critical care drug products affirmed the enrollment of first patient into the Mino-Lok Phase 3 Clinical Trial for…
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Eisai asserts positive results of Phase 3 Study for lenvatinib mesylate

Feb 16, 2018
Eisai declared positive results of Phase 3 study for its discovered and developed anticancer agent lenvatinib mesylate in patients grappling with unresectable hepatocellular carcinoma…
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Merck KGaA and Pfizer assert Phase III JAVELIN Lung 200 trial results

Feb 16, 2018
Merck KGaA, Darmstadt, Germany, and Pfizer assert results from the Phase III JAVELIN Lung 200 trial comparing avelumab to docetaxel in patients with unresectable, recurrent or…
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