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Edwards Lifesciences announced one-year data highlighting the continued outstanding performance of its SAPIEN 3 Ultra RESILIA valve

Written by | 4 Dec 2024

Edwards Lifesciences  announced one-year data highlighting the continued outstanding performance of its SAPIEN 3 Ultra RESILIA valve. The data were presented at PCR London Valves 2024 and simultaneously… read more.

GSK’s fully liquid Menveo meningococcal vaccine approved by European Commission – GSK

Written by | 3 Dec 2024

GSK plc announced that the European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (Meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine)… read more.

Zai Lab and Pfizer announced a strategic collaboration for Xacduro (sulbactam-durlobactam) in mainland China – Zai Lab + Pfizer

Written by | 2 Dec 2024

Zai Lab and Pfizer  announced  a strategic collaboration for the novel antibacterial drug Xacduro (sulbactam-durlobactam) in mainland China. Pfizer’s affiliated companies will be exclusively authorized to undertake and… read more.

NICE (UK) recommends teclistamab as an option for treating relapsed and refractory multiple myeloma – Johnson & Johnson

Written by | 1 Dec 2024

NICE (UK) 1.1Teclistamab is recommended as an option for treating relapsed and refractory multiple myeloma in adults, only after 3 or more lines of treatment (including an immunomodulatory… read more.

FDA clearance for InPen app featuring missed meal dose detection, paving the way for the launch of its Smart MDI system with the Simplera continuous glucose monitor – Medtronic

Written by | 30 Nov 2024

Medtronic plc announced FDA clearance for its new InPen app featuring missed meal dose detection, paving the way for the launch of its Smart MDI system with the Simplera… read more.

FDA accepts sNDA for Nubeqa (darolutamide) plus ADT to treat metastatic hormone-sensitive prostate cancer – Bayer

Written by | 29 Nov 2024

Bayer  announced that the  FDA has accepted the company’s supplemental new drug application (sNDA) for the oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide) in combination with androgen deprivation… read more.

FDA approves Aucatzyl (obecabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia – Autolus Therapeutics

Written by | 28 Nov 2024

Autolus Therapeutics plc  an early-commercial stage biopharmaceutical company developing next-generation programmed T cell therapies, announces the FDA has granted marketing approval for Aucatzyl   (obecabtagene autoleucel) for the… read more.

Positive three-year primary endpoint results from the OPTION global clinical trial of the Watchman FLX Left Atrial Appendage Closure Device – Boston Scientific

Written by | 27 Nov 2024

Boston Scientific Corporation announced positive three-year primary endpoint results from the OPTION global clinical trial of the Watchman FLX Left Atrial Appendage Closure (LAAC) Device. Key findings from… read more.

Royal Philips launches next-generation 1.5T BlueSeal MR wide-bore scanner

Written by | 26 Nov 2024

Royal Philips, a global leader in health technology, announced its next-generation 1.5T BlueSeal MR wide-bore scanner will be unveiled at RSNA 2024. The latest generation scanner features a… read more.

Tagrisso (osimertinib) recommended for approval in the EU by CHMP for patients with unresectable EGFR-mutated lung cancer – AstraZeneca

Written by | 25 Nov 2024

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on the results from the LAURA Phase III trial,… read more.

FDA approval for Danziten (nilotinib) to treat Philadelphia chromosome positive chronic myeloid leukemia – Azurity Pharma

Written by | 24 Nov 2024

Azurity Pharmaceuticals announced that the FDA has approved Danziten, the first and only nilotinib with no mealtime restrictions indicated for adult patients with newly diagnosed Philadelphia chromosome positive… read more.

FDA grants accelerated approval for Kebilidi (eladocagene exuparvovec-tneq) for the treatment of AADC deficiency – PTC Therapeutics

Written by | 23 Nov 2024

PTC Therapeutics, Inc.  announced  the FDA accelerated approval of its gene therapy for the treatment of AADC deficiency, the first-ever gene therapy approved in the United States that… read more.

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