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acute pancreatitis

Pharma & Biotech

Ionis Pharmaceuticals moves beyond rare disease as Tryngolza enters the wider triglyceride market

Tryngolza is no longer confined to the rare familial chylomicronemia syndrome market. Its broader United States approval gives clinicians the first therapy specifically shown to reduce acute pancreatitis risk in adults with severe hypertriglyceridemia, although questions surrounding dose selection, hepatic monitoring, reimbursement and long-term use will influence how quickly the treatment changes practice.

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Pharma & Biotech

Does the FDA’s KOURAGE response restore confidence in CalciMedica’s CRAC platform?

CalciMedica can continue developing Auxora after the FDA reviewed KOURAGE safety data without imposing a clinical hold, but a large financing, major potential dilution and a strategic shift toward pulmonary hypertension redefine the CALC investment case.

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Pharma & Biotech

Arrowhead’s plozasiran clears CHMP: what a positive opinion for FCS means for siRNA’s regulatory arc in Europe

Plozasiran clears CHMP but the real test is reimbursement. Europe's HTA bodies will now decide whether clinical FCS diagnosis is enough.

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