Eton Announces Commercial Availability of Nitisinone Capsules
Torrent's Generic Nitisinone Receives Approval in the U.S.
Swedish Orphan Biovitrum AB (publ) (Sobi), a specialised international biopharmaceutical company, announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Orfadin (nitisinone) for the treatment of adult patients with alkaptonuria (AKU), the first described human genetic disease. The opinion is now referred to the European Commission for a decision.
EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its September 2020 meeting.
STOCKHOLM, Sept. 18, 2020 /PRNewswire/ -- Swedish Orphan Biovitrum AB (publ) (Sobi™) today announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Orfadin® (nitisinone) for the treatment of adult patients with alkaptonuria (AKU), the first described human genetic disease. The opinion is now referred to the European Commission for a decision.
RadioMedix’s Detectnet (copper Cu 64 dotatate injection) has been approved for the detection of somatostatin receptor‒positive neuroendocrine tumors (NETs) in adult patients during imaging with positron emission tomography.
BOSTON--(BUSINESS WIRE)--Cycle Pharmaceuticals is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the once daily dosing of NITYR®.
Cycle Pharmaceuticals, a privately-owned, global, patient-dedicated biotechnology company focused on developing and delivering medicines for rare diseases, today announced that it has executed a definitive agreement for a $25 million credit facility with Deutsche Bank AG. This strategic financing allows Cycle to build on the success of NITYR® (nitisinone) Tablets, which treats patients with the rare genetic metabolic disease, hereditary tyrosinemia type 1. Cycle’s mission is to utilise the latest pharmaceutical technologies to deliver best-in-class drug treatments to better serve rare genetic disease patients.
Novitium Pharma`s Generic Nitisinone Receives Approval in US
Celgene Europe BV Generic Azacitidine Receives Approval in Europe