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BD Surgiphor surgical wound irrigation system launched in Europe to help hospitals improve patient safety – Becton, Dickinson and Company

Written by | 31 Dec 2025

BD (Becton, Dickinson and Company) announced the launch of the BD Surgiphor Surgical Wound Irrigation System in Europe. The system is the first of its kind to receive… read more.

New study validates Guardant Reveal blood test’s effectiveness in monitoring chemotherapy response in solid tumours – Guardant Health

Written by | 29 Dec 2025

Guardant Health Inc. announced new data demonstrating that its Guardant Reveal blood test helps clinicians to assess the effectiveness of chemotherapy in patients with advanced solid tumors months… read more.

Organon announces agreement to divest its JADA System for treating postpartum hemorrhage for up to $465 Million to Laborie

Written by | 28 Dec 2025

Organon announced that it has entered into an agreement with Laborie Medical Technologies Corp., a leading diagnostic and therapeutic medical technology company, for them to acquire the JADA… read more.

Positive topline results announced from Phase III study of sparsentan in Japanese patients with IgA nephropathy – Renalys Pharma/Chugai

Written by | 27 Dec 2025

Chugai and Renalys Pharma, Inc. announced positive topline results from its Phase III clinical study of sparsentan (RE 021), an orally administered dual endothelin and angiotensin II receptor… read more.

Exdensur (depemokimab) approved by FDA for the treatment of severe asthma – GSK

Written by | 26 Dec 2025

GSK plc announced that the FDA has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and paediatric patients… read more.

Novo Nordisk files submission to FDA for approval of a higher dose of Wegovy (semaglutide) injection 7.2 mg

Written by | 23 Dec 2025

Novo Nordisk announced the submission of a sNDA to the U.S. Food and Drug Administration (FDA) for a higher dose of semaglutide injection 7.2 mg, to be used… read more.

GE HealthCare unveils Pristina Recon DL for mammography – deep learning image reconstruction technology delivering clearer image quality

Written by | 22 Dec 2025

GE HealthCare announced that it has received FDA Premarket Authorization for Pristina Recon DL, an advanced 3D mammography image reconstruction technology. Powered by deep learning, Pristina Recon DL… read more.

First U.S. sales of Komzifti (ziftomenib) triggers $135 Million milestone payment to Kura Oncology under collaboration and license agreement with Kyowa Kirin

Written by | 21 Dec 2025

Kura Oncology, Inc. announced the first U.S. commercial sale of Komzifti (ziftomenib) has been completed. Under Kura’s collaboration and license agreement with Kyowa Kirin Co. Ltd. and Kyowa… read more.

FDA approves Daybue Stix (trofinetide) for oral solution for the treatment of Rett syndrome – Acadia Pharmaceuticals

Written by | 20 Dec 2025

Acadia Pharmaceuticals announced that the FDA has approved Daybue Stix (trofinetide) for oral solution, a dye- and preservative-free powder formulation of trofinetide for the treatment of Rett syndrome… read more.

FDA approves Avance nerve graft for the treatment of adult and pediatric patients aged 1 month or older with sensory, mixed, and motor peripheral nerve discontinuities – Axogen

Written by | 19 Dec 2025

Axogen, Inc. announced that the FDA has approved the Biologics License Application (“BLA”) for Avance (acellular nerve allograft-arwx). Avance is an acellular nerve scaffold for the treatment of… read more.

Insulet announces FDA 510(k) clearance of Omnipod 5 algorithm enhancements that redefine insulin delivery and simplify the pod experience

Written by | 18 Dec 2025

Insulet Corporation, a global leader in tubeless insulin pump technology with its Omnipod brand of products, today announced it has received FDA 510(k) clearance for significant enhancements to… read more.

Positive Phase III trial results for Hemgenix (etranacogene dezaparvovec-drlb) in adults living with hemophilia B – CSL

Written by | 17 Dec 2025

CSL announced five-year (60-month) results from the pivotal Phase III HOPE-B study, confirming the long-term durability and safety of a one-time infusion of Hemgenix (etranacogene dezaparvovec-drlb) in adults… read more.

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