Zealand Pharma announced that the FDA has accepted for filing the company’s New Drug Application (NDA) for the HypoPal Rescue Pen (dasiglucagon) for the treatment of hypoglycemia in… read more.
Genentech, a member of the Roche Group will present new pooled pivotal satralizumab safety results for the treatment of neuromyelitis optica spectrum disorder (NMOSD) , a rare, debilitating… read more.
Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Applications (MAA) for both idecabtagene vicleucel (ide-cel, bb2121) and CC 486. Validation of… read more.
Abbott has announced a government contract to supply millions of its laboratory-based IgG antibody tests to National Health Service (NHS) laboratories across the UK over the coming months…. read more.
Advanced Biological Laboratories (ABL) announced the CE-IVD registration of its UltraGene Combo2Screen SARS-CoV-2 assay, now available for in-vitro diagnostics use. This test is intended to be used for… read more.
Abbott announced it received Health Canada authorization under the COVID-19 Interim Order for the ARCHITECT SARS-CoV-2 IgG test, a laboratory-based serology blood test for the detection of the… read more.
Astellas Pharma Inc. and FibroGen, Inc. announced the marketing authorization application (MAA) for roxadustat for the treatment of anemia in adult patients with chronic kidney disease (CKD) has… read more.
Incyte and MorphoSys AG announced the validation of the European Marketing Authorization Application (MAA) for tafasitamab, an anti-CD19 antibody. The application seeks approval of tafasitamab in combination with… read more.
Gilead Sciences, Inc. and Galapagos NV announced positive topline results from SELECTION, a randomized, double-blind, placebo-controlled, Phase IIb/III trial evaluating the efficacy and safety of the investigational, oral,… read more.
Roche Canada announced that Health Canada has granted market authorization to Rozlytrek (entrectinib) for the treatment of patients with ROS1-positive, locally advanced or metastatic non-small cell lung cancer… read more.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced updated results from the Phase 1b/II CARTITUDE-1 study (NCT03548207) evaluating the efficacy and safety of JNJ 4528, an investigational… read more.
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders announced the interim analysis of the HIV Prevention Trials… read more.
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