Blog
RSS FeedPosted by Michael Wonder on 25 Sep 2024
GSK’s Menveo meningococcal vaccine in new single-vial, fully liquid presentation receives positive European CHMP opinion
24 September 2024 - Marketing authorisation in EU expected by November 2024. ...
Posted by Michael Wonder on 24 Sep 2024
European Commission approves Leo Pharma’s Anzupgo (delgocitinib) cream for adults with moderate to severe chronic hand eczema
23 September 2024 - Anzupgo is the first topical treatment to be specifically indicated for adult patients living with moderate to ...
Posted by Michael Wonder on 24 Sep 2024
Ipsen’s Kayfanda (odevixibat) approved in European Union for cholestatic pruritus in Alagille Syndrome, a rare liver disease
23 September 2024 - E.U. marketing authorization for Kayfanda based on data from ASSERT the only Phase 3 trial completed in ...
Posted by Michael Wonder on 24 Sep 2024
Merck receives positive EU CHMP opinions for Keytruda (pembrolizumab) regimens as treatment for patients with two types of gynaecologic cancers
20 September 2024 - Positive opinion granted for Keytruda plus chemotherapy for the first-line treatment of adult patients with primary advanced ...
Posted by Michael Wonder on 23 Sep 2024
Fasenra recommended for approval in the EU by CHMP for the treatment of eosinophilic granulomatosis with polyangiitis
23 September 2024 - New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and ...
Posted by Michael Wonder on 23 Sep 2024
Henlius and Intas receive positive CHMP opinion for Hetronifly in European markets as first-line treatment for adult patients with extensive-stage small cell lung cancer
21 September 2024 - Hetronifly (serplulimab) is expected to become the first anti-PD-1 monoclonal antibody available in Europe for first-line treatment ...
Posted by Michael Wonder on 22 Sep 2024
Wegovy recommended by the European regulatory authorities for label update to reflect reduced heart failure symptoms and improved physical function
19 September 2024 - Novo Nordisk today announced that the EMA's CHMP has adopted a positive opinion for an update of ...
Posted by Michael Wonder on 21 Sep 2024
Astellas receives approval from the European Commission for Vyloy (zolbetuximab) in combination with chemotherapy for advanced gastric and gastro-oesophageal junction cancer
20 September 2024 - Treatment with the claudin 18.2 targeted monoclonal antibody shown to significantly extend both progression-free survival and ...
Posted by Michael Wonder on 20 Sep 2024
Dupixent (dupilumab) recommended for EU approval by the CHMP to treat eosinophilic oesophagitis in children as young as 1 year old
20 September 2024 - Recommendation based on a Phase 3 trial showing a significantly greater proportion of children on Dupixent achieved ...
Posted by Michael Wonder on 20 Sep 2024
AbbVie receives positive CHMP opinion for mirvetuximab soravtansine (Elahere) for the treatment of certain adult ovarian cancer
20 September 2024 - AbbVie today announced that the EMA's CHMP has adopted a positive opinion recommending the marketing authorisation of ...
Posted by Michael Wonder on 20 Sep 2024
Bavarian Nordic receives EMA approval of mpox vaccine for adolescents
19 September 2024 - MVA-BN approved for use against mpox and smallpox in adolescents 12-17 years of age after expedited review ...
Posted by Michael Wonder on 19 Sep 2024
Valneva submits label extension applications for its chikungunya vaccine Ixchiq to EMA and Health Canada
18 September 2024 - To potentially include adolescents and antibody persistence up to two years. ...
Posted by Michael Wonder on 18 Sep 2024
EMA publishes agenda for 16-19 September 2024 CHMP meeting
16 September 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 13 Sep 2024
Johnson & Johnson seeks first EU approval of nipocalimab to treat a broad population of patients living with antibody-positive generalised myasthenia gravis
12 September 2024 - Janssen-Cilag today announced the submission of the marketing authorisation application to the EMA) seeking first approval ...
Posted by Michael Wonder on 11 Sep 2024
Pierre Fabre Laboratories receives European Commission approval for Braftovi (encorafenib) in combination with Mektovi (binimetinib) for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation
30 August 2024 - European approval is based on results from the Phase 2 PHAROS trial, which showed a meaningful ...