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CHMP suggests AstraZeneca and Merck’s selumetinib for paediatric patients pharmaceutical-technology
April 28, 2021
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended AstraZeneca and Merck’s (MSD) selumetinib for conditional marketing authorisation in the EU for treating children aged three years and ...
Selumetinib Granted Orphan Drug Designation in Japan for Neurofibromatosis Type 1 americanpharmaceuticalreview
July 09, 2020
AstraZeneca announced selumetinib has been granted orphan drug designation (ODD) in Japan for the treatment of neurofibromatosis type 1 (NF1), a rare and debilitating genetic disease.
FDA Approves Selumetinib for Neurofibromatosis Type 1 americanpharmaceuticalreview
April 15, 2020
The Food and Drug Administration (FDA) approved selumetinib (KOSELUGO, AstraZeneca) for pediatric patients, 2 years of age and older, with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
FDA grants AstraZeneca-Merck’s selumetinib breakthrough therapy designation pharmaceutical-technology
April 03, 2019
AstraZeneca has announced the US Food and Drug Administration (FDA) has granted selumetinib, a MEK 1/2 inhibitor co-commercialised with Merck, breakthrough therapy designation.
Selumetinib granted US Breakthrough Therapy Designation in neurofibromatosis type 1 worldpharmanews
April 03, 2019
The Association of the British Pharmaceutical Industry has called for a temporary ban on drugs exports in the event of a no-deal Brexit to prevent the NHS being hit by shortages…
AZ’s Selumetinib granted US Breakthrough Therapy Designation pharmatimes
April 02, 2019
AstraZeneca and MSD have announced the granting of Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) for its MEK 1/2 inhibitor and potential new medicine selumetinib.
Selumetinib Granted Orphan Designation in Europe americanpharmaceuticalreview
August 06, 2018
AstraZeneca and Merck announced that the European Medicines Agency (EMA) has granted orphan designation to selumetinib, a MEK 1/2 inhibitor, for the treatment of neurofibromatosis type 1 (NF1).
AstraZeneca’s selumetinib flops in thyroid cancer, adding to list of failures fiercepharma
July 30, 2018
As it has been tussling over licensing checks and trying to gain a reprieve, AstraZeneca quietly announced in the midst of its quarterly update this morning that selumetinib has once again missed the mark in a cancer test.