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Calliditas Therapeutics AB

https://www.calliditas.se/en/

Latest From Calliditas Therapeutics AB

PTC’s ‘Life-Changing’ Gene Therapy Among Nine Drugs To Win EU Thumbs Up

The European Medicines Agency has delivered its verdict on the latest medicines it believes should be approved for marketing in the EU. By contrast, it has given the thumbs down to one biosimilar anticancer drug and its duplicate.

Europe Approvals

Stada Poised To Launch As Calliditas Finally Wins EU Nod For Kinpeygo

The Swedish biotech’s patience paid off as it received a positive EU CHMP opinion on its rare nephrology drug Kinpeygo, known elsewhere as Tarpeyo, following delays related to manufacturing questions.

Approvals Renal

EU Marketing Decisions For New Drugs Imminent For Sanofi, PTC, Calliditas & Others

The European Medicines Agency’s human medicines committee, the CHMP, is expected to decide whether 11 drugs should be recommended for marketing approval during its latest monthly meeting, which started today.

Drug Review Europe

Calliditas’ Nephrology Gem Tarpeyo Faces EU Regulatory Delay

The Swedish biotech’s oral corticosteroid for a kidney disorder has left the EMA’s CHMP with questions on its manufacturing, delaying an EU approval opinion that had been slated for the first quarter.

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