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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.

European Commission approves Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma – BMS

Written by | 23 Jun 2024

Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable… read more.

FDA approves expanded age indication for Arexvy, the first respiratory syncytial virus (RSV) vaccine for adults aged 50-59 at increased risk – GSK

Written by | 22 Jun 2024

GSK plc announced that the FDA has approved Arexvy (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50… read more.

FDA approves Klisyri (tirbanibulin) for the treatment of actinic keratosis on expanded area of face or scalp up to 100 cm – Almirall

Written by | 21 Jun 2024

Almirall, announced that the FDA has approved Almirall’s recent supplemental New Drug Application (sNDA) to expand the use area for its drug, Klisyri, to up to 100 cm…. read more.

European Commission authorization for Lytenava (bevacizumab gamma) for the treatment of Wet AMD – Outlook Therapeutics

Written by | 20 Jun 2024

Outlook Therapeutics, Inc., a biopharmaceutical company focused on the commercialization and development of ONs-5010/Lytenava (bevacizumab-vikg; bevacizumab gamma), for the treatment of retina diseases, announced that the European Commission… read more.

CHMP positive recommendation for Eliquis (apixaban) to treat venous thromboembolism (VTE) and prevention of recurrent VTE in children – BMS + Pfizer

Written by | 19 Jun 2024

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Eliquis… read more.

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