Future Medicine India – Drug Approvals Drug Approvals Archives | Future Medicine India

Drug Approvals

Givosiran to treat acute hepatic porphyria

The US FDA has granted approval to givosiran (Givlaari) for the treatment of adult patients with acute hepatic porphyria.

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EMA panel recommends fostamatinib to treat ITP

CHMP has adopted a positive opinion for Rigel Pharmaceuticals’ MAA for fostamatinib disodium hexahydrate for the treatment of chronic immune thrombocytopenia

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Rare paediatric disease designation for sarizotan

The US FDA has granted the Rare Pediatric Disease designation for sarizotan for the treatment of Rett syndrome, a rare neurodevelopmental disorder primarily affecting females.

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CHMP recommends polatuzumab combo for DLBCL

Roche said the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for polatuzumab vedotin (Polivy) in combination with bendamustine plus rituximab (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

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Solriamfetol for narcolepsy in Europe

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the marketing authorisation of solriamfetol to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy.

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Crizanlizumab for vaso-occlusive crisis in SCD

USFDA has approved crizanlizumab (Adakveo) as the first therapy to reduce the frequency of vaso-occlusive crisis, a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells, Novartis said.

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Tepotinib gets Japanese orphan drug designation to treat NSCLC

The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted orphan drug designation (ODD) for tepotinib for patients with non-small cell lung cancer (NSCLC) harbouring MET gene alterations.

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