Seegene, Inc. announced that U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for its Allplex 2019-nCoV Assay, a Real-time RT-PCR test for SARS-CoV-2, the novel… read more.
Myovant Sciences announced that it has submitted a New Drug Application (NDA) to the FDA for once-daily, oral relugolix (120 mg) for the treatment of men with advanced… read more.
Cara Therapeutics and Vifor Fresenius Medical Care Renal Pharma announced positive topline data from Cara’s KALM-2 pivotal Phase III trial of Korsuva (CR845/difelikefalin) Injection in hemodialysis patients with… read more.
Bristol-Myers Squibb announced that CheckMate -743, a pivotal Phase III trial evaluating Opdivo (nivolumab) in combination with Yervoy (ipilimumab) in previously untreated malignant pleural mesothelioma (MPM) met its… read more.
Alexion Pharmaceuticals, Inc.announced plans to initiate a global Phase III study to investigate Ultomiris (ravulizumab-cwvz) in a subset of adults with COVID-19 – those who are hospitalized with… read more.
Bristol Myers Squibb and Exelixis, Inc. announced that CheckMate -9ER, a pivotal Phase III trial evaluating Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) compared to sunitinib in previously… read more.
Novartis has reached an agreement with the FDA to proceed with a Phase III clinical trial with approximately 440 patients to evaluate the use of hydroxychloroquine for the… read more.
Incyte announced the initiation of RUXCOVID, a global, randomized, double-blind, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of ruxolitinib (Jakafi) plus standard-of-care (SoC) in patients… read more.
Incyte announced that the FDA has approved Pemazyre (pemigatinib), a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with… read more.
Seattle Genetics, Inc. announced the FDA granted approval to Tukysa(tucatinib) tablets in combination with trastuzumab and capecitabine for adult patients with advanced unresectable (cannot be surgically removed) or… read more.
Axsome Therapeutics, Inc. announced that AXS 07 substantially and significantly eliminated migraine pain, and substantially and significantly prevented progression of migraine pain intensity in the INTERCEPT Phase III… read more.
Abbott announced the launch of its third COVID-19 test, a lab-based serology blood test for the detection of the antibody, IgG, that identifies if a person has had… read more.
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