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CHMP recommends Jyseleca, a once daily treatment for Rheumatoid Arthritis.- Gilead Sciences + Galapagos NV

Written by | 25 Jul 2020

Gilead Sciences, Inc.and Galapagos NV announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Jyseleca (filgotinib 200… read more.

CHMP recommends approval of GSK 2857916 in multiple myeloma.- GlaxoSmithKline

Written by | 25 Jul 2020

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of GSK 2857916 (belantamab mafodotin), from… read more.

CHMP recommends approval of Imbruvica + Rituxan for chronic lymphocytic leukaemia.- Janssen

Written by | 25 Jul 2020

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a Positive Opinion… read more.

CHMP recommends approval of Arikayce for non-tuberculous mycobacterial lung infections.- Insmed

Written by | 25 Jul 2020

Insmed announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending Arikayce (liposomal 590 mg nebuliser… read more.

FDA approves CAR T cell therapy Tecartus for mantle cell lymphoma.- Kite Pharma/Gilead Sciences

Written by | 25 Jul 2020

Kite Pharma/Gilead Sciences announced that the FDA has granted accelerated approval to Tecartus (brexucabtagene autoleucel, formerly KTE-X19), the first and only approved chimeric antigen receptor (CAR) T cell… read more.

CHMP recommends approval of Crysvita for X-linked hypophosphataemia.- Kyowa Kirin

Written by | 25 Jul 2020

Kyowa Kirin announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the expanded approval of Crysvita (burosumab) to… read more.

CHMP negative recommendation for emapalumab for the treatment of primary haemophagocytic lymphohistiocytosis.- Swedish Orphan Biovitrium

Written by | 25 Jul 2020

Swedish Orphan Biovitrum AB (publ) (Sobi™) announced that the Committee for Medicinal Products for Human use (CHMP) has adopted a negative opinion recommending a refusal of the marketing… read more.

Adakveo receives positive CHMP opinion for the prevention of recurrent vaso-occlusive crises in patients with sickle cell disease.- Novartis

Written by | 25 Jul 2020

Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending conditional marketing authorization of Adakveo… read more.

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