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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.

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.

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.

GE HealthCare announces CE Mark for the Omni 128cm total body PET/CT system

Written by | 8 Dec 2025

GE HealthCare announced CE Mark for its next-generation Omni 128cm total body positron emission tomography / computed tomography (PET/CT) system, a major milestone in its mission to advance… 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.

Abbott initiates medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the US

Written by | 5 Dec 2025

Abbott has initiated a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the United States after internal testing determined that some… read more.

Rigel Pharma announces publication of final 5-year data on Rezlidhia (olutasidenib) in patients with R/R mIDH1 AML in the Journal of Hematology & Oncology

Written by | 4 Dec 2025

Rigel Pharmaceuticals Inc. announced a peer-reviewed publication in the Journal of Hematology & Oncology of the final five-year data from the pivotal cohort of the Phase II registrational… read more.

GE HealthCare announces CE Mark for the new digital 4D SPECT/CT system, StarGuide GX

Written by | 3 Dec 2025

GE HealthCare announced CE Mark for its StarGuide GX a new digital 4D SPECT/CT system designed with excellent precision, clinical efficiency and impressive versatility. This milestone marks a… read more.

Ono Pharma Receives Supplemental Approval in Japan for combination therapy with Braftovi (encorafenib) capsule, a BRAF Inhibitor, for colorectal cancer

Written by | 2 Dec 2025

Ono Pharmaceutical Co., Ltd. announced that they received  supplemental approval in Japan for Braftovi  (encorafenib) capsule in combination with cetuximab, an anti-human EGFR monoclonal antibody, and chemotherapy for… read more.

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