EMA ap­proves Boehringer's sys­temic scle­ro­sis ther­a­py; No­var­tis' Kym­ri­ah wins RMAT sta­tus for fol­lic­u­lar lym­phoma

→ The Eu­ro­pean Com­mis­sion has ap­proved Boehringer In­gel­heim‘s nintedanib for sys­temic scle­ro­sis-as­so­ci­at­ed in­ter­sti­tial lung dis­ease (SSc-ILD) in adults. The OK fol­lows the Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use’s pos­i­tive opin­ion on Feb­ru­ary 27.

→ Kym­ri­ah, the first-ever CAR-T ap­proved ther­a­py, has been grant­ed the Re­gen­er­a­tive Med­i­cine Ad­vanced Ther­a­py (RMAT) des­ig­na­tion by the FDA for use in re­lapsed or re­frac­to­ry fol­lic­u­lar lym­phoma, No­var­tis said. If ap­proved for the in­di­ca­tion, that will be Kym­ri­ah’s third ap­proval — it is al­ready sanc­tioned for use in acute lym­phoblas­tic leukemia and adult dif­fuse large B-cell lym­phoma.

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