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Omvoh (mirikizumab-mrkz) approved by FDA as a single-injection maintenance regimen in adults with ulcerative colitis – Eli Lilly

Written by | 15 Dec 2025

Eli Lilly and Company announced that the FDA approved a single-injection, once-monthly maintenance regimen (200 mg/2 mL) of Omvoh (mirikizumab-mrkz) for subcutaneous use in adults with moderately to… read more.

European Commission approves Brinsupri (brensocatib) as the first anctd only treatment approved for non-cystic fibrosis bronchieasis in the EU – Insmed

Written by | 14 Dec 2025

Insmed  announced that the European Commission has approved  Brinsupri  (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and… read more.

Roche receives FDA clearance with CLIA waiver and CE Mark for its first point-of-care test for diagnosing Bordetella infections, including whooping cough (pertussis)

Written by | 13 Dec 2025

Roche announced  that its first point-of-care test for the diagnosis of whooping cough (pertussis) and other Bordetella infections, has been granted FDA 510(k) clearance and Clinical Laboratory Improvement… read more.

FDA approves Tezspire (tezepelumab) for chronic rhinosinusitis with nasal polyps – Amgen+ AstraZeneca

Written by | 12 Dec 2025

Amgen and AstraZeneca  announced that the FDA approved Tezspire  (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric… read more.

NICE (UK) positive for Nubeqa (darolutamide) with androgen deprivation therapy for treating hormone-sensitive metastatic prostate cancer – Bayer

Written by | 11 Dec 2025

NICE (UK): Darolutamide with androgen deprivation therapy (ADT) can be used as an option to treat hormone-sensitive metastatic prostate cancer in adults, only if: i) docetaxel is not… read more.

VolitionRx shows biomarker-driven lung cancer insights at NACLC 2025

Written by | 10 Dec 2025

VolitionRx Limited, announces the presentation of two abstracts at the North America Conference on Lung Cancer (NACLC) in Chicago recently. The posters highlighted the use of its Nu.Q® Cancer… read more.

Sandoz launches denosumab biosimilars in Europe, providing affordable treatment option for cancer-related bone disease and osteoporosis for millions of patients

Written by | 10 Dec 2025

Sandoz announced the European launch of Wyost (denosumab 120 mg) and Jubbonti (denosumab 60 mg). The medicines are among the first denosumab biosimilars to launch in Europe and are approved… read more.

Medtronic begins U.S. commercial launch of the MiniMed 780G system with the Instinct sensor, made by Abbott

Written by | 9 Dec 2025

Medtronic announced the broad U.S. commercial launch of the MiniMed 780G system integrated with the Instinct sensor, made by Abbott and designed exclusively for MiniMed systems. Following U.S…. read more.

Alvotech announces approval of AVT 03, a biosimilar to Prolia and Xgeva (denosumab) in the European Economic Area

Written by | 7 Dec 2025

Alvotech announced that the European Commission (EC) has approved AVT 03 as a biosimilar to Prolia and Xgeva (denosumab). AV T03 is approved in two presentations: as a… read more.

Lundbeck to present eight new analyses on bexicaserin at AES 2025, reinforcing sustained seizure-reduction potential across DEEs

Written by | 6 Dec 2025

Lundbeck A/S (Lundbeck) announced that new pipeline data regarding bexicaserin (LP352), a novel investigational drug for the treatment of seizures associated with Developmental and Epileptic Encephalopathies (DEEs), will… read more.

FDA approves Redemplo (plozasiran) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome – Arrowhead

Written by | 6 Dec 2025

Arrowhead Pharmaceuticals, Inc. announced that the FDA has approved Redemplo (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet to reduce triglycerides in adults with… read more.

UCB announces 21 data presentations spanning clinical research and real-world insights at AES 2025

Written by | 5 Dec 2025

UCB, a global biopharmaceutical company, today announced it will present 21 abstracts at the American Epilepsy Society (AES) Annual Meeting (December 5-9, 2025). Data include primary efficacy and… read more.

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