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Final results for VV116 (mindeudesivir hydrobromide) shows efficacy in COVID 19 trial – Junishi Biosciences

Written by | 2 Dec 2023

Junshi Biosciences has revealed the final results for its Covid-19 pill VV 116 (mindeudesivir hydrobromide), indicating its efficacy. The data, which was published in The Lancet Infectious Diseases… read more.

FGFR inhibitor erdafitinib for urothelial cancer is filed in Japan – Janssen Pharmaceutical

Written by | 1 Dec 2023

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.

MHLW (Japan) orders label revisions to five anticoagulants to advise the risk of kidney injury

Written by | 30 Nov 2023

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 expands hepatitis diagnostics portfolio to help clinicians diagnose and monitor patients with acute or chronic hepatitis B infection

Written by | 29 Nov 2023

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.

European Commission approval for Brukinsa (zanubrutinib) for the treatment of relapsed or refractory follicular lymphoma – BeiGene

Written by | 28 Nov 2023

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 presents new cardiovascular research at AHA meeting

Written by | 27 Nov 2023

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.

FDA approves Symplicity Spyral renal denervation (RDN) system for treatment of hypertension – Medtronic

Written by | 26 Nov 2023

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 announces major step towards sustainability ambitions with advancement of low carbon Ventolin programme to Phase III trials

Written by | 25 Nov 2023

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.

FDA approval of world’s first chikungunya vaccine, Ixchiq – Valneva SE

Written by | 24 Nov 2023

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.

FDA approval of expanded approval for expanded Exparel label to include two additional nerve block indications – Pacira Biosciences

Written by | 23 Nov 2023

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 closes acquisition of Relievant Medsystems, Inc. and with it Intracept Intraosseous Nerve Ablation System

Written by | 22 Nov 2023

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.

FDA approval for DefenCath (taurolidine and heparin) catheter lock solution to reduce the incidence of catheter-related bloodstream infections – CorMedix

Written by | 21 Nov 2023

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.

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