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510(k) FDA clearance of the VELYS Robotic-assisted solution for use in unicompartmental knee athroplasty procedures – DePuy Synthes

Written by | 8 Jul 2024

Johnson & Johnson MedTech announced that DePuy Synthes, The Orthopaedics Company of Johnson & Johnson, has received 510(k) FDA clearance for the clinical application of the VELYS™ Robotic-Assisted… read more.

Kisunla (donanemab-azbt) approved by the FDA for the treatment of early symptomatic Alzheimer’s disease – Eli Lilly

Written by | 7 Jul 2024

The FDA approved Kisunla (donanemab-azbt, 350 mg/20 mL once-monthly injection for IV infusion), Eli Lilly and Company’s Alzheimer’s treatment for adults with early symptomatic Alzheimer’s disease (AD), which… read more.

FDA grants full approval to selpercatinib for RET+ thyroid cancer – Eli Lilly

Written by | 5 Jul 2024

The FDA has granted full approval to selpercatinib (Retevmo) from Eli Lilly for the treatment of adult and pediatric patients at least 2 years of age with advanced… read more.

FDA approves Skyrizi (risankizumab-rzaa) for ulcerative colitis, expanding AbbVie’s portfolio across inflammatory bowel disease

Written by | 4 Jul 2024

AbbVie announced the FDA has approved Skyrizi (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis, making it the first IL-23 specific inhibitor approved for both moderate… read more.

CHMP positive for Vabysmo (faricimab) marketing authorisation to include the treatment of visual impairment due to macular edema secondary to retinal vein occlusion – Roche

Written by | 3 Jul 2024

Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the extension of the Vabysmo (faricimab) marketing… read more.

MHLW (Japan) approved Omjjara (momelotinib) for the treatment of myelofibrosis – GSK

Written by | 2 Jul 2024

GSK plc announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Omjjara (momelotinib) for the treatment of myelofibrosis. Omjjara is a once-a-day, oral JAK1/JAK2 and… read more.

Wegovy (semaglutide) is approved by NMPA (China) for long-term weight management for overweight and obese people – Novo Nordisk

Written by | 30 Jun 2024

Novo Nordisk’s weight-loss drug Wegovy has been approved for sale in China, opening the door to a huge market in which obesity rates have more than doubled among… read more.

Johnson & Johnson MedTech releases the Polyphonic Digital Ecosystem for a more connected surgical experience

Written by | 29 Jun 2024

Johnson & Johnson MedTech unveiled Polyphonic, the open and secure digital ecosystem for a more connected surgical experience. The ecosystem features software applications that are agnostic to data… read more.

First presentations of Bimzelx (bimekizumab) two-year data in axial spondyloarthritis and psoriatic arthritis at EULAR 2024 – UCB

Written by | 28 Jun 2024

UCB, announced the first presentation of two-year data from the Phase III studies, BE MOBILE 1 and BE MOBILE 2, and the open-label extension, BE MOVING, evaluating bimekizumab,… read more.

Farxiga (dapagliflozin) approved in the US for the treatment of paediatric type-2 diabetes – AstraZeneca

Written by | 27 Jun 2024

AstraZeneca’s Farxiga (dapagliflozin) has been approved by the FDA to improve glycaemic control in paediatric patients with type-2 diabetes (T2D) aged 10 years and older. The FDA approval… read more.

FDA accepts filing of Leqembi (lecanemab-irmb) supplemental biologics license application for IV maintenance dosing for the treatment of early Alzheimer’s disease – Eisai + Biogen

Written by | 26 Jun 2024

Eisai Co. Ltd. and Biogen Inc. announced that that the FDA has accepted Eisai’s Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (U.S. brand name: Leqembi) intravenous (IV)… read more.

Safety and efficacy profile of Lupkynis (voclosporin) for people with lupus nephritis presented at European Alliance of Associations for Rheumatology Congress – Aurinia Pharma

Written by | 25 Jun 2024

Aurinia Pharmaceuticals Inc. announced an oral presentation at the European Alliance of Associations for Rheumatology (EULA R) 2024 taking place in Vienna, Austria June 12-15. The data reinforces… read more.

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