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RSS FeedPosted by Michael Wonder on 20 Sep 2023
CHMP adopts positive opinion to extend the use of Veklury (remdesivir) to treat COVID-19 in people with hepatic impairment
19 September 2023 - This positive opinion reinforces Veklury’s strong safety profile. ...
Posted by Michael Wonder on 20 Sep 2023
Tyenne, Fresenius Kabi’s tocilizumab biosimilar, receives European Commission approval
19 September 2023 - Tyenne is the first tocilizumab biosimilar approved by the European Commission. ...
Posted by Michael Wonder on 20 Sep 2023
Otsuka and Astex announce that the European Commission has approved Inaqovi (oral decitabine and cedazuridine) for the treatment of adults with newly diagnosed acute myeloid leukaemia
19 September 2023 - Otsuka and Astex Pharmaceuticals today announce that the European Commission has approved Inaqovi (oral decitabine and ...
Posted by Michael Wonder on 20 Sep 2023
European Commission approves Pfizer’s Litfulo for adolescents and adults with severe alopecia areata
19 September 2023 - Pfizer today announced that the European Commission has granted marketing authorisation for Litfulo (ritlecitinib) to treat adults ...
Posted by Michael Wonder on 19 Sep 2023
Cellectar Biosciences receives European Medicines Agency Priority Medicines (PRIME) designation for iopofosine for Waldenstrom’s macroglobulinaemia
18 September 2023 - The EMA’s PRIME status is granted to drug candidates that may offer a major therapeutic advantage over ...
Posted by Michael Wonder on 19 Sep 2023
Ebglyss (lebrikizumab) receives positive CHMP opinion for moderate to severe atopic dermatitis
15 September 2023 - Positive opinion is based on Phase 3 studies which showed long-term response in skin clearance and itch ...
Posted by Michael Wonder on 18 Sep 2023
BioMarin receives positive CHMP opinion in Europe to expand use of Voxzogo (vosoritide) to treat children aged 4 months and older with achondroplasia
15 September 2023 - BioMarin today announced that the EMA's CHMP has adopted a positive opinion recommending marketing authorisation to expand ...
Posted by Michael Wonder on 18 Sep 2023
Ascendis Pharma receives positive CHMP opinion for TransCon PTH (palopegteriparatide) for adults with chronic hypoparathyroidism
14 September 2023 - Final European Commission decision expected within 67 days after positive opinion; if approved, first European Union ...
Posted by Michael Wonder on 18 Sep 2023
Sandoz receives positive CHMP opinion for breast and gastric cancer biosimilar trastuzumab
18 September 2023 - Positive CHMP opinion based on comprehensive package of analytical, pre-clinical and clinical data. ...
Posted by Michael Wonder on 17 Sep 2023
Highlights from the 11-14 September 2023 CHMP meeting
15 September 2023 - The EMA’s CHMP recommended nine medicines for approval at its September 2023 meeting. ...
Posted by Michael Wonder on 16 Sep 2023
argenx announces positive CHMP opinion for subcutaneous efgartigimod for generalised myasthenia gravis
15 September 2023 - Positive opinion based on Phase 3 ADAPT-SC study demonstrating non-inferior total IgG reduction at day 29 with ...
Posted by Michael Wonder on 16 Sep 2023
Quizartinib recommended for approval in EU by CHMP for patients with newly diagnosed FLT3-ITD positive AML
15 September 2023 - Positive opinion based on QuANTUM-First results demonstrating quizartinib combined with standard chemotherapy improved overall survival. ...
Posted by Michael Wonder on 16 Sep 2023
EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna
15 September 2023 - EMA’s human medicines committee (CHMP) has recommended not renewing the marketing authorisation for Translarna (ataluren), a ...
Posted by Michael Wonder on 16 Sep 2023
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) as adjuvant treatment for adults with non-small cell lung cancer at high risk of recurrence following complete resection and platinum-based chemotherapy
15 September 2023 - Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial. ...
Posted by Michael Wonder on 16 Sep 2023
Vertex receives CHMP positive opinion for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor for children with cystic fibrosis ages 2 through 5
15 September 2023 - If approved, more than 1,200 children would be newly eligible for a medicine that could treat ...