501 Results

FDA approves subcutaneous formulation of Benlysta (belimumab) for systemic lupus erythematosus- GlaxoSmithKline

 Added 1 day ago

The FDA has approved a new subcutaneous formulation of Benlysta (belimumab), from GlaxoSmithKline, for the treatment of adult patients with...

EU CHMP recommends approval of Xermelo (telotristat ethyl) for carcinoid syndrome diarrhea - Lexicon Pharmaceuticals

 Added 1 day ago

Lexicon Pharmaceuticals announced that the Committee for Medicinal Products for Human Use, the committee of the European Medicines Agency responsible...

EU CHMP recommends approval of Rydapt (midostaurin) for systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm or mast cell leukemia- Novartis

 Added 1 day ago

Novartis announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion...

EU Commission approves Kyntheum (brodalumab) of moderate-to-severe plaque psoriasis.- Leo Pharma

 Added 3 days ago

AstraZeneca and MedImmune, announced that its partner Leo Pharma has been granted full marketing authorisation in all 28 EU member...

FDA approves Tremfya (guselkumab) to treat plaque psoriasis.- Janssen Biotech.

 Added 9 days ago

Janssen Biotech, Inc. announced that the FDA has approved Tremfya (guselkumab) for the treatment of adults living with moderate to...

FDA clears the way for Amicus Therapeutics to submit an NDA to the agency for for the oral precision medicine migalastat for Fabry disease in the fourth quarter of 2017.

 Added 11 days ago

Amicus Therapeutics plans to submit a new drug application (NDA) to the FDA for the oral precision medicine migalastat for...

FDA approves Orencia (abatacept) for active Psoriatic Arthritis- BMS

 Added 17 days ago

The FDA has approved Orencia (abatacept), from BMS, for the treatment of adults with active Psoriatic Arthritis (PsA), a chronic,...

CHMP approves label update for Cosentyx (secukinumab) to treat moderate-to-severe scalp psoriasis. - Novartis

 Added 17 days ago

Novartis has announced that the Committee for Medicinal Products for Human Use (CHMP) has approved a label update for Cosentyx...

Nucala (mepolizumab) filed with FDA as an add-on therapy to corticosteroids for the treatment of adult patients with Eosinophilic Granulomatosis with Polyangiitis- GlaxoSmithKline

 Added 25 days ago

GlaxoSmithKline announced the submission of a supplemental Biologics License Application (sBLA) to the United States Food and Drug Administration (FDA),...

Orencia (abatacept) is CHMP recommended to treat active psoriatic arthritis (PsA).-BMS.

 Added 28 days ago

The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending a change to the terms...

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