Janssen Pharmaceutical has filed a new drug application in Japan for its oral fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor erdafitinib for the treatment of certain patients… read more.
The Ministry of Health, Labor and Welfare (MHLW) on November 21 ordered label revisions for five anticoagulants to newly advise the risk of acute kidney injury, including Bristol… read more.
Roche announced the launch of Elecsys HBeAg quant, an immunoassay that is able to determine both the presence and quantity (qualitative and quantitative) of the hepatitis B e… read more.
BeiGene, Ltd. announced that the European Commission (EC) has granted marketing authorization for Brukinsa (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with relapsed or… read more.
Amgen announced new data reinforcing the safety and efficacy of Repatha (evolocumab) from the FOURIER Open Label Extension (OLE) [FOURIER-OLE] trial at the American Heart Association (AHA) Scientific… read more.
Medtronic plc announced that the FDA has approved the Symplicity Spyral renal denervation (RDN) system, also known as the Symplicity blood pressure procedure, for the treatment of hypertension…. read more.
GSK plc announced it will start Phase III trials of a low carbon version of its metered dose inhaler (MDI), Ventolin (salbutamol), using a next generation propellant, in… read more.
Valneva SE announced that the FDA has approved Ixchiq, Valneva’s single-dose, live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years… read more.
Pacira BioSciences, Inc. announced that the FDA has approved its supplemental new drug application (sNDA) to expand the Exparel (bupivacaine liposome injectable suspension) label to include administration in… read more.
Boston Scientific Corporation announced the close of its acquisition of Relievant Medsystems Inc., a company that offers the only FDA -cleared Intracept Intraosseous Nerve Ablation System, a therapy… read more.
CorMedix Inc. announced that the FDA has approved DefenCath (taurolidine and heparin) catheter lock solution (CLS) to reduce the incidence of catheter-related bloodstream infections (CRBSIs) for the limited… read more.
Health Canada has approved the gene therapy Hemgenix (etranacogene dezaparvovec) for treating adults with hemophilia B who rely on routine prophylactic therapies to prevent or reduce bleeding episodes…. read more.
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