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RSS FeedPosted by Michael Wonder on 18 Dec 2023
CHMP issues positive opinion for Biogen’s Skyclarys (omaveloxolone), the first therapy to treat Friedreich’s ataxia, a rare neurodegenerative disease
15 December 2023 - Biogen announced the CHMP of the EMA recommended marketing authorisation for Skyclarys (omaveloxolone) for the treatment ...
Posted by Michael Wonder on 18 Dec 2023
EMA recommends arpraziquantel for treatment of schistosomiasis in pre-school aged children
17 December 2023 - Astellas contributed to the development of a paediatric formulation to treat schistosomiasis as a member of ...
Posted by Michael Wonder on 17 Dec 2023
Takeda receives positive CHMP opinion for Hyqvia as maintenance therapy in patients with chronic inflammatory demyelinating polyneuropathy
15 December 2023 - Positive opinion based on Phase 3 ADVANCE-CIDP 1 study, which met its primary endpoint demonstrating a statistically ...
Posted by Michael Wonder on 16 Dec 2023
Vertex receives CHMP positive opinion for the first CRISPR/Cas9 gene-edited therapy, Casgevy (exagamglogene autotemcel), for the treatment of sickle cell disease and transfusion-dependent beta thalassaemia
15 December 2023 - If approved by the European Commission, patients 12 years of age and older with severe sickle cell ...
Posted by Michael Wonder on 12 Dec 2023
The European Commission granted marketing authorisation for Vueway (gadopiclenol) in the European Union
11 December 2023 - Vueway is a new, highly stable, macrocyclic gadolinium-based contrast agent (GBCA) for contrast-enhanced magnetic resonance imaging (CE-MRI): ...
Posted by Michael Wonder on 11 Dec 2023
GSK’s Jemperli (dostarlimab) plus chemotherapy approved as the first and only frontline immuno-oncology treatment in the European Union for dMMR/MSI-H primary advanced or recurrent endometrial cancer
11 December 2023 - European Commission also converts previous conditional approval for Jemperli to full approval as a monotherapy for ...
Posted by Michael Wonder on 10 Dec 2023
Astellas' Veoza (fezolinetant) approved by European Commission for treatment of vasomotor symptoms associated with menopause
10 December 2023 - First in class treatment option reduces number and intensity of hot flashes and night sweats ...
Posted by Michael Wonder on 08 Dec 2023
European Commission approves Pfizer’s Elrexfio for relapsed and refractory multiple myeloma
8 December 2023 - Conditional marketing authorisation is based on clinically meaningful response rates, duration of response, and safety from the ...
Posted by Michael Wonder on 04 Dec 2023
UCB announces European Commission approval of Zilbrysq (zilucoplan) for the treatment of adults with generalised myasthenia gravis
4 December 2023 - Approval supported by pivotal Phase 3 RAISE study in generalised myasthenia gravis which demonstrated treatment with zilucoplan ...
Posted by Michael Wonder on 23 Nov 2023
European Commission approves Kaftrio in combination with ivacaftor for the treatment of children with cystic fibrosis ages 2 through 5
23 November 2023 - More than 1,200 children are newly eligible for a medicine that could treat the underlying cause ...
Posted by Michael Wonder on 22 Nov 2023
EC approves pharmaand’s Rubraca as advanced ovarian cancer maintenance treatment
21 November 2023 - The European Commission has approved pharmaand’s Rubraca (rucaparib) as a first-line maintenance treatment for advanced ovarian cancer ...
Posted by Michael Wonder on 21 Nov 2023
Ascendis Pharma announces European Commission approval of Yorvipath (palopegteriparatide) for the treatment of adults with chronic hypoparathyroidism
20 November 2023 - Ascendis plans its first EU launch of Yorvipath in Germany in January 2024. ...
Posted by Michael Wonder on 18 Nov 2023
Halozyme announces argenx receives European Commission approval of Vvyvart SC with Enhanze for generalised myasthenia gravis
16 November 2023 - Vyvgart SC now approved for subcutaneous administration, adding to the already approved IV administration. ...
Posted by Michael Wonder on 18 Nov 2023
BeiGene receives European Commission approval for Brukinsa (zanubrutinib) for the treatment of relapsed or refractory follicular lymphoma
17 November 2023 - Approval was based on results from the ROSEWOOD trial in which Brukinsa plus the anti-CD20 monoclonal ...
Posted by Michael Wonder on 18 Nov 2023
Almirall receives European Commission Approval of Ebglyss (lebrikizumab) for moderate to severe atopic dermatitis
17 November 2023 - Following the European Commission approval, Germany is the first country where lebrikizumab will be available for prescription. ...