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RSS FeedPosted by Michael Wonder on 18 Nov 2024
AbbVie receives European Commission approval of Elahere (mirvetuximab soravtansine) for the treatment of platinum resistant ovarian cancer
18 November 2024 - VENTANA FOLR RxDx assay, the companion diagnostic to identify ovarian cancer patients eligible for Elahere, also ...
Posted by Michael Wonder on 16 Nov 2024
Bristol Myers Squibb receives positive CHMP opinion for repotrectinib for the treatment of advanced ROS1 positive non-small cell lung cancer and advanced NTRK positive solid tumours
15 November 2024 - Recommendation based on data from registrational TRIDENT-1 and CARE trials, which demonstrated robust responses and durable activity ...
Posted by Michael Wonder on 15 Nov 2024
Bristol Myers Squibb receives positive CHMP opinion for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high or mismatch repair deficient metastatic colorectal cancer
15 October 2024 - Opinion based on results from the Phase 3 CheckMate-8HW trial, in which the dual immunotherapy combination ...
Posted by Michael Wonder on 15 Nov 2024
Highlights from the 11-14 November 2024 CHMP meeting
15 November 2024 - The EMA’s CHMP has recommended eight medicines for approval at its November 2024 meeting. ...
Posted by Michael Wonder on 15 Nov 2024
Sandoz receives European Commission approval for Afqlir (aflibercept), further strengthening leading biosimilar portfolio
15 November 2024 - Afqlir (aflibercept) approved to treat various retinal diseases, including neovascular age-related macular degeneration. ...
Posted by Michael Wonder on 15 Nov 2024
Leqembi recommended for treatment of early Alzheimer’s disease
14 November 2024 - After re-examining its initial opinion, EMA’s CHMP has recommended granting a marketing authorisation to Leqembi (lecanemab) ...
Posted by Michael Wonder on 14 Nov 2024
EMA publishes agenda for 11-14 November 2024 CHMP meeting
11 November 2024 - - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 08 Nov 2024
Johnson & Johnson submits applications in the US and EU seeking approval of Darzalex Faspro/Darzalex as subcutaneous monotherapy for high risk smoldering multiple myeloma
8 November 2024 - If approved, Darzalex Faspro will become the first treatment option for patients with smoldering multiple myeloma at ...
Posted by Michael Wonder on 06 Nov 2024
Dupixent (dupilumab) approved in the European Union as the first and only medicine for young children with eosinophilic oesophagitis
6 November 2024 - Approval based on Phase 3 data showing significantly more children aged 1 to 11 years on ...
Posted by Michael Wonder on 05 Nov 2024
European Medicines Agency confirms acceptance of marketing authorisation application for AVT05, a proposed biosimilar to Simponi (golimumab)
4 November 2024 - Alvotech and Advanz Pharma today announced that the EMA has accepted a marketing authorisation application for AVT05, ...
Posted by Michael Wonder on 28 Oct 2024
Astellas provides update on marketing authorisation application for avacincaptad pegol in the European Union
28 October 2024 - Astellas today announced the company's decision to withdraw its marketing authorisation application from the EMA for ...
Posted by Michael Wonder on 28 Oct 2024
Fasenra approved in the EU for eosinophilic granulomatosis with polyangiitis
28 October 2024 - New indication supported by the MANDARA trial, which showed nearly 60% of patients achieved remission and ...
Posted by Michael Wonder on 24 Oct 2024
Merck’s Keytruda (pembrolizumab) receives 30th approval from European Commission with two new indications in gynaecologic cancers
24 October 2024 - Keytruda plus chemotherapy is the first approval in the EU for an anti-PD-1 therapy combined with chemotherapy ...
Posted by Michael Wonder on 22 Oct 2024
CHMP recommends the approval of Dong-A ST’s Imuldosa, a biosimilar to Stelara
21 October 2024 - Dong-A ST announced on 18 October 2024 that its biosimilar Imuldosa (ustekinumab, development code DMB-3115), referencing ...
Posted by Michael Wonder on 22 Oct 2024
Highlights from the 14-17 October 2024 CHMP meeting
18 October 2024 - The CHMP recommended granting a marketing authorisation for Alhemo (concizumab), a medicine for routine prophylaxis of ...