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Pharma & Biotech

Pharma & Biotech

NewAmsterdam Pharma and Menarini win EU approval for Ubeslo and Evlarco

NewAmsterdam Pharma Company N.V. and Menarini Group have secured European marketing authorisations for Ubeslo and Evlarco, turning obicetrapib into a commercial-stage cholesterol therapy while leaving PREVAIL to answer the more consequential question of whether its LDL reductions translate into fewer cardiovascular events.

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Pharma & Biotech

AMT-130 four-year data extend Huntington’s disease signal as FDA evaluates uniQure BLA

uniQure reports four-year ifezuntirgene data showing slower Huntington’s disease progression as its gene therapy BLA moves through FDA review.

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Pharma & Biotech

Novo Nordisk bets up to $2.6bn on Hengrui’s once-weekly oral GLP-1/GIP drug

Novo Nordisk licenses Hengrui’s once-weekly oral GLP-1/GIP candidate HRS-1596 in a deal worth up to $2.6 billion.

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Pharma & Biotech

Evorpacept biomarker signal deepens in HER2-positive gastric cancer as ALX Oncology shifts focus

ALX Oncology’s evorpacept raises response to 63.6% in a HER2-retained, CD47-high gastric cancer subgroup, supporting biomarker-led development.

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Pharma & Biotech

Teva wins FDA approval for DEGEVMA biosimilar across all Xgeva indications

FDA approves Teva’s DEGEVMA as an Xgeva biosimilar across oncology bone-disease indications, expanding its U.S. denosumab portfolio.

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Pharma & Biotech

One Carvykti infusion, five years without maintenance: Johnson & Johnson’s tiny trial delivers a striking myeloma signal

Five-year CARTITUDE-2 data show 50% of 20 early-line relapsed multiple myeloma patients remained alive and progression-free after a single Carvykti infusion without maintenance therapy, strengthening the case for using CAR-T before heavily pretreated disease.

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Pharma & Biotech

MediciNova stock up 85% in September as pivotal ALS trial reaches final patient visit

MediciNova has completed the final patient visit in the blinded portion of its 234-patient COMBAT-ALS study, starting the countdown to pivotal MN-166 results expected by year-end as MNOV shares emerge as one of September’s strongest-performing healthcare stocks.

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Pharma & Biotech

Merck KGaA’s $11.3bn Bio-Techne deal clears shareholder vote as life-science tools consolidation advances

Bio-Techne shareholders have approved Merck KGaA’s $11.3 billion cash acquisition, clearing a major hurdle in a transaction designed to expand the German group across multi-omics, spatial biology, precision diagnostics and cell therapy workflows.

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Pharma & Biotech

FDA sets January decision for Pharming Group’s lower-dose Joenja pediatric expansion

FDA grants Priority Review to lower-dose Joenja for children with APDS weighing 13–27 kg, setting a January 30, 2027 decision date.

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Pharma & Biotech

Five-year CARVYKTI data deepen evidence for durable remission in earlier-line multiple myeloma

CARVYKTI keeps half of CARTITUDE-2 patients progression-free and treatment-free at five years after one infusion. See what the data mean.

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