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Vivos Therapeutics receives first ever FDA 510(k) clearance for oral device treatment of severe obstructive sleep apnea

Written by | 6 Dec 2023

Vivos Therapeutics, Inc. announced that it has been granted 510(k) clearance from the FDA for treating severe obstructive sleep apnea (OSA) in adults using the Vivos’ removable CARE… read more.

Update on CRYSTALIZE evidence trials for Lokelma (sodium zirconium cyclosilicate) for hyperkalaemia – AstraZeneca

Written by | 5 Dec 2023

AstraZeneca has decided to discontinue the STABILIZE-CKD and DIALIZE-Outcomes Phase III evidence trials for Lokelma (sodium zirconium cyclosilicate) . The decision was made due to substantially increased enrolment… read more.

Rheumacensus experts unite and call for essential psoriatic arthritis and axial spondyloarthritis care improvements – UCB

Written by | 4 Dec 2023

As part of its longstanding commitment to patients in rheumatology, UCB, a global biopharmaceutical company, is sponsoring an expert-led, multi-stakeholder programme called Rheumacensus. The programme aims to identify… read more.

Positive results from DREAMM-7 head-to-head phase III trial for Blenrep (belantamab mafodotin) in relapsed/refractory multiple myeloma – GSK

Written by | 3 Dec 2023

GSK plc announced positive headline results from a planned interim efficacy analysis of the DREAMM-7 head-to-head phase III trial evaluating belantamab mafodotin as a second-line treatment for relapsed… read more.

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.

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