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RSS FeedPosted by Michael Wonder on 02 Jul 2024
Pierre Fabre Laboratories announce granting of European marketing authorisation for Obgemsa (vibegron) in overactive bladder
28 June 2024 - The European Commission has authorised the marketing of Obgemsa (vibegron) by Pierre Fabre Laboratories for the symptomatic ...
Posted by Michael Wonder on 02 Jul 2024
Valneva receives marketing authorisation in Europe for the world’s first chikungunya vaccine Ixchiq
1 July 2024 - 2024 – Valneva today announced that the European Commission has granted marketing authorisation in Europe for Valneva’s ...
Posted by Michael Wonder on 01 Jul 2024
CHMP recommends EU approval of Roche’s PiaSky for people with PNH, a rare, life-threatening blood condition
28 June 2024 - The recommendation is based on the COMMODORE 2 study results, where SC PiaSky given every month demonstrated ...
Posted by Michael Wonder on 01 Jul 2024
Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention
1 July 2024 - Submission based on positive SUPERNOVA Phase 3 trial data which demonstrated a statistically significant reduction in ...
Posted by Michael Wonder on 01 Jul 2024
Lynparza and Imfinzi combination recommended for approval in the EU by CHMP for patients with mismatch repair proficient advanced or recurrent endometrial cancer
1 July 2024 - Recommendation based on DUO-E Phase 3 results, which showed both regimens demonstrated statistically significant and clinically ...
Posted by Michael Wonder on 30 Jun 2024
Roche’s Vabysmo gets CHMP recommendation for third indication retinal vein occlusion
28 June 2024 - Positive recommendation is based on two Phase 3 studies. In addition to robust retinal drying with Vabysmo, ...
Posted by Michael Wonder on 29 Jun 2024
Highlights from the 24-27 June 2024 CHMP meeting
28 June 2024 - The EMA’s CHMP recommended ten medicines for approval at its June 2024 meeting. ...
Posted by Michael Wonder on 29 Jun 2024
Iovance Biotherapeutics submits marketing authorisation application to European Medicines Agency for lifileucel in advanced melanoma
28 June 2024 - First of multiple planned global submissions for lifileucel in 2024 and 2025. ...
Posted by Michael Wonder on 28 Jun 2024
Odronextamab recommended for EU approval by the CHMP to treat relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma
28 June 2024 - Recommendation based on data from the Phase 1 and pivotal Phase 2 trials demonstrating robust and ...
Posted by Michael Wonder on 28 Jun 2024
Pfizer and BioNTech receive positive CHMP opinion for omicron JN.1 adapted COVID-19 Vaccine in the European Union
27 June 2024 - The updated COVID-19 vaccine is tailored to the Omicron JN.1 lineage of SARS-CoV-2 and is recommended for ...
Posted by Michael Wonder on 28 Jun 2024
AbbVie receives positive CHMP opinion for epcoritamab (Tepkinly) for the treatment of adults with relapsed/refractory follicular lymphoma
28 June 2024 - Positive CHMP opinion based on results from the Phase 1/2 EPCORE NHL-1 study. ...
Posted by Michael Wonder on 27 Jun 2024
Bavarian Nordic submits marketing authorisation application for its chikungunya vaccine candidate to EMA
26 June 2024 - Regulatory review of the single-dose CHIKV VLP vaccine candidate for immunization to prevent disease caused by ...
Posted by Michael Wonder on 26 Jun 2024
Tofidence (tocilizumab), a biosimilar referencing RoActemra, approved in the European Union
24 June 2024 - Tofidence complements existing portfolio of immunology biosimilars commercialised by Biogen ...
Posted by Michael Wonder on 26 Jun 2024
ExCellThera announces EMA’s acceptance under accelerated assessment of market authorisation application for UM171 cell therapy for patients with haematological malignancies who lack a readily available suitable donor
25 June 2024 - ExCellThera announced today that the market authorisation application for UM171 cell therapy (INN-dorocubicel) has been accepted under ...
Posted by Michael Wonder on 25 Jun 2024
Roche’s Ocrevus subcutaneous administration approved by European Commission, as first and only twice-a-year injection for relapsing and primary progressive multiple sclerosis
25 June 2024 - Roche is working closely with national health systems in Europe to ensure people with multiple sclerosis ...