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Successful patient outcomes demonstrated with SAPIEN M3 and EVOQUE systems as mitral and tricuspid therapies – new data presented at TCT 2025 – Edwards Lifesciences

Written by | 1 Dec 2025

Edwards Lifesciences announced data demonstrating successful patient outcomes supporting its portfolio of mitral and tricuspid therapies. One-year data from the ENCIRCLE single-arm pivotal trial achieved all primary and… read more.

CHMP adopts a positive opinion for change to the terms of the marketing authorisation for Paxlovid – Pfizer

Written by | 30 Nov 2025

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Paxlovid (nirmatrelvir + ritonavir)…. read more.

Update provided on Phase III ASCENT-07 study of Trodelvy (sacituzumab govitecan) in metastatic breast cancer – Gilead Sciences

Written by | 29 Nov 2025

Gilead Sciences Inc. announced the Phase III ASCENT-07 study investigating Trodelvy (sacituzumab govitecan-hziy) versus chemotherapy as a first-line treatment post-endocrine therapy in HR+/HER2-negative metastatic breast cancer patients did… read more.

NICE(UK) positive for Apretude (cabotegravir) for preventing HIV-1 in adults and young people – ViiV Healthcare

Written by | 28 Nov 2025

NICE(UK): Cabotegravir is recommended as an option for pre-exposure prophylaxis (PrEP) alongside safer sex practices to reduce the risk of sexually acquired HIV-1 infection in adults and young… read more.

New Analysis reinforces Vascepa/Vaskepa (icosapent ethyl) reduced cardiovascular events in high-risk patients – Amarin

Written by | 27 Nov 2025

Amarin Corporation highlighted a new post hoc analysis of aspirin use in REDUCE-IT® reinforcing that icosapent ethyl significantly reduced cardiovascular (CV) events in high-risk patients. These findings highlight the… read more.

NICE (UK) terminated appraisal for Ofev (nintedanib) for treating fibrosing interstitial lung disease in people 6 to 17 years – Boehringer Ingelheim

Written by | 26 Nov 2025

NICE(UK): NICE is unable to make a recommendation about the use in the NHS of nintedanib for treating fibrosing interstitial lung disease in people 6 to 17 years…. read more.

CHMP adopts a positive opinion for VacPertagen, a pertussis vaccine – BioNet

Written by | 25 Nov 2025

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for VacPertagen, a vaccine intended for prophylaxis against pertussis. The applicant… read more.

New data announced from Phase IIIb TRuE-AD4 trial of Opzelura (ruxolitinib cream) in adults with moderate atopic dermatitis – Incyte

Written by | 24 Nov 2025

Incyte announced new data from the Phase IIIb TRuE-AD4 study evaluating the efficacy and safety of Opzelura (ruxolitinib cream) in adults with moderate atopic dermatitis (AD) who had… read more.

Xofluza Granules 2% – a new formulation for influenza treatment and prophylaxis launched – Shionogi

Written by | 23 Nov 2025

Shionogi & Co., Ltd.  announced the launch  of a new formulation of the anti-influenza virus drug Xofluza (baloxavir marboxil) – Xofluza Granules 2%. Until now, Xofluza has only… read more.

Wegovy (semaglutide 2.4 mg) associated with liver health-related benefits not solely based on weight loss in adult patients with MASH with liver scarring, according to a new post hoc analysis – Novo Nordisk

Written by | 22 Nov 2025

Novo Nordisk presented data at the 76th annual American Association for the Study of Liver Diseases (AASLD) meeting, The Liver Meeting 2025, in Washington, D.C., evaluating the effects… read more.

Lundbeck files for marketing authorization across key Asian markets for Vyepti (eptinezumab) for the preventive treatment of migraine

Written by | 21 Nov 2025

Lundbeck announced the  acceptance of its new drug application (NDA) for Vyepti  (eptinezumab) by the Ministry of Health, Labor and Welfare (MHLW) in Japan. The submission reflects the… read more.

Roche receives CE mark for novel automated high-throughput Elecsys Dengue Ag test to diagnose dengue

Written by | 20 Nov 2025

Roche announced that it has received CE mark for its Elecsys Dengue Ag test – a high-throughput, fully automated immunoassay to be used as an aid in the… read more.

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