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RSS FeedPosted by Michael Wonder on 28 Jun 2022
Xenpozyme (olipudase alfa) approved by European Commission as first and only treatment for ASMD
28 June 2022 - The European Commission has approved Xenpozyme (olipudase alfa) as the first and only enzyme replacement therapy for ...
Posted by Michael Wonder on 28 Jun 2022
Adverum Biotechnologies granted Priority Medicines (PRIME) designation by EMA for ADVM-022 in wet AMD
24 June 2022 - Adverum Biotechnologies today announced that the EMA has granted ADVM-022 Priority Medicines (PRIME) designation for the treatment ...
Posted by Michael Wonder on 28 Jun 2022
Curium announces the submission of its marketing authorisation application for [18F]-DCFPyL to the EMA
27 June 2022 - Submission follows the completion of Phase III PYTHON clinical trial of [18F]-DCFPyL for recurrent prostate cancer in ...
Posted by Michael Wonder on 27 Jun 2022
European Commission approves Keytruda (pembrolizumab) as adjuvant treatment for adult and adolescent patients (≥12 years of age) with stage IIB or IIC melanoma following complete resection
24 June 2022 - Approval based on recurrence-free survival and distant metastasis-free survival benefit demonstrated by KEYTRUDA in the Phase 3 ...
Posted by Michael Wonder on 27 Jun 2022
FYB201, Formycon's biosimilar for Lucentis (ranibizumab), receives CHMP recommendation from EMA
24 June 2022 - Formycon and its licensing partner Bioeq announce that the CHMP of the EMA today issued a ...
Posted by Michael Wonder on 27 Jun 2022
Lynparza recommended for approval in the EU by CHMP as adjuvant treatment for patients with germline BRCA mutated HER2 negative high risk early breast cancer
27 June 2022 - First PARP inhibitor to improve overall survival in early-stage breast cancer. ...
Posted by Michael Wonder on 27 Jun 2022
CHMP recommends approval of upadacitinib (Rinvoq) for the treatment of adults with active non-radiographic axial spondyloarthritis
27 June 2022 - CHMP positive opinion is based on results from the Phase 3 SELECT-AXIS 2 study showing upadacitinib (RINVOQ®) ...
Posted by Michael Wonder on 27 Jun 2022
Trastuzumab deruxtecan recommended for approval in the EU by CHMP for patients with HER2 positive metastatic breast cancer treated with a prior anti-HER2 based regimen
27 June 2022 - Recommendation based on DESTINY-Breast03 trial results showing Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan reduced the risk ...
Posted by Michael Wonder on 27 Jun 2022
Celltrion Healthcare receives CHMP positive opinion for biosimilar bevacizumab, Vegzelma (CT-P16)
27 June 2022 - The positive opinion is based on the totality of evidence including the Phase III study to evaluate ...
Posted by Michael Wonder on 26 Jun 2022
CHMP issues a positive opinion recommending full approval of Oncopeptides Pepaxti in EU for patients with triple class refractory multiple myeloma
23 June 2022 - Oncopeptides today announces that the EMA's CHMP, has unanimously adopted a positive opinion recommending a full marketing ...
Posted by Michael Wonder on 26 Jun 2022
argenx receives positive CHMP opinion for efgartigimod for the treatment of adult patients with generalised myasthenia gravis in Europe
24 June 2022 - Positive opinion based on Phase 3 ADAPT trial showing efgartigimod provided clinically meaningful improvements in strength and ...
Posted by Michael Wonder on 26 Jun 2022
First gene therapy to treat severe haemophilia A
24 June 2022 - EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Roctavian (valoctocogene roxaparvovec) ...
Posted by Michael Wonder on 26 Jun 2022
Highlights from the 20-23 June 2022 CHMP meeting
24 June 2022 - EMA’s CHMP recommended nine medicines for approval at its June 2022 meeting. ...
Posted by Michael Wonder on 26 Jun 2022
Investigational lenacapavir receives positive CHMP opinion for people with multi-drug resistant HIV
24 June 2022 - Recommendation is based on week 26 data from the CAPELLA trial showing twice yearly lenacapavir achieved high ...
Posted by Michael Wonder on 25 Jun 2022
Novartis receives positive CHMP opinion for Scemblix, a novel treatment for adult patients with chronic myeloid leukaemia
24 June 2022 - ...