PRINCETON, N.J., Sept. 21, 2023 (GLOBE NEWSWIRE) -- Medunik USA (member of Duchesnay Pharmaceutical Group) is pleased to announce that government coverage of Siklos® (hydroxyurea, HU) under State...
MIAMI, Feb. 25, 2022 /PRNewswire/ -- Brand Institute is proud to announce its successful partnership with Global Blood Therapeutics (GBT) in naming their EMA-approved therapy, OXBRYTA, indicated for the treatment of hemolytic anemia due to sickle cell disease (SCD) in adult and pediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide (hydroxyurea). This follows FDA and Health Canada approval of the therapy in 2019.
LONDON, Jan. 27, 2022 (GLOBE NEWSWIRE) -- Global Blood Therapeutics (GBT) today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has awarded a positive scientific opinion under the Early Access to Medicines Scheme (EAMS) for voxelotor, an oral once-daily tablet under review by the MHRA for the treatment of haemolytic anaemia due to sickle cell disease (SCD) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide. This positive opinion means that those patients living with SCD and meeting the eligibility criteria can gain early, pre-license access to voxelotor, while the MHRA completes its review of the Marketing Authorisation Application (MAA).
Global Blood Therapeutics (GBT) have announced the CHMP adopted a npositive opinion recommending marketing authorisation for Oxbryta® n (vocelotor) tablets. Oxbryta is for the treatment of haemolytic anaemiandue to sickle cell disease (SCD) in adults and paediatric patients 12 nyears of age and older, as a monotherapy or in combination with nhydroxycarbamide (hydroxyurea).
Novartis' Adakveo (crizanlizumab) has hit a setback having failed to gain acceptance by the National Institute for Health and Care Excellence (NICE).
Basel, October 30, 2020 — Novartis today announced that the European Commission (EC) has approved Adakveo (crizanlizumab) for the prevention of recurrent vaso-occlusive crises (VOCs), or pain crises, in patients with sickle cell disease aged 16 years and older.1 Adakveo can be given as an add-on therapy to hydroxyurea/hydroxycarbamide (HU/HC) or as monotherapy in patients for whom HU/HC is inappropriate or inadequate.
ROSEMONT, Pa., Oct. 19, 2020 /PRNewswire/ - Medunik USA is proud to announce that Siklos® (hydroxyurea), indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in children, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crises1, is now available in a 100 mg scored tablet in addition to the 1,000 mg triple-scored tablets.
Leading Pharma`s Generic Hydroxyurea Receives Approval In US
Nova Laboratories has announced details of its “revolutionary” new liquid formation of hydroxycarbamide for sickle cell disease.
ROSEMONT, PA, Aug. 21, 2018 /PRNewswire/ - Medunik USA, a company dedicated to improving the health and quality of life of Americans with rare diseases by making orphan drugs available in the U.S., announced today that Siklos® (hydroxyurea), an FDA-approved orphan drug, is now available in 100 mg tablets for pharmacies to order.