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EC grants orphan drug status to Dicerna’s DCR-A1AT to treat congenital A1AT deficiency pharmaceutical-business-review
December 20, 2019
Dicerna Pharmaceuticals has secured orphan drug designation from the European Commission (EC) for its DCR-A1AT to treat congenital alpha-1 antitrypsin (A1AT) deficiency.
AbbVie Receives EC Approval of RINVOQ for Rheumatoid Arthritis americanpharmaceuticalreview
December 19, 2019
AbbVie announced the European Commission (EC) has approved RINVOQ™ (upadacitinib) for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have ...
EC approves treatment for severe osteoporosis postmenopausal women europeanpharmaceuticalreview
December 16, 2019
Marketing authorisation has been granted by the EC for Evenity® (romosozumab) to treat osteoporosis in postmenopausal women.
Amgen-UCB’s Evenity receives EC approval to treat osteoporosis pharmaceutical-technology
December 16, 2019
Amgen and UCB have received the European Commission (EC) approval for Evenity (romosozumab) to treat severe osteoporosis in postmenopausal women at high fracture risk.
EC approves expanded indication for cystic fibrosis treatment europeanpharmaceuticalreview
December 12, 2019
The European Commission has approved the label extension for KALYDECO® (ivacaftor) to include the treatment of infants with cystic fibrosis between six and 12 months old.
EC Grants Orphan Drug Designation for Nirogacestat for Soft Tissue Sarcoma americanpharmaceuticalreview
September 25, 2019
SpringWorks Therapeutics announced the European Commission has granted Orphan Drug Designation for nirogacestat, an oral, selective, small molecule, gamma-secretase inhibitor, for the treatment of soft tissue sarcoma.
EC expands label of Janssen’s Stelara to include ulcerative colitis pharmaceutical-technology
September 10, 2019
Johnson & Johnson subsidiary Janssen has announced the European Commission (EC) has approved Stelara (ustekinumab) for patients with moderately to severely active ulcerative colitis (UC).
EC approves expanded use of ustekinumab for ulcerative colitis europeanpharmaceuticalreview
September 09, 2019
The biologic treatment ustekinumab has been granted an expanded use for ulcerative colitis within the EU.
EC approves Roche’s Tecentriq combination to treat breast cancer pharmaceutical-technology
September 03, 2019
Roche has gained approval from the European Commission (EC) for Tecentriq (atezolizumab) with chemotherapy (Abraxane) to treat patients with unresectable locally advanced or...
La Jolla Receives European Commission Approval for Giapreza americanpharmaceuticalreview
September 03, 2019
La Jolla announced that the European Commission (EC) has approved GIAPREZA™ (angiotensin II) for the treatment of refractory hypotension in adults with septic or other distributive shock...

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