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RSS FeedPosted by Michael Wonder on 30 Mar 2025
EMA validates Henlius and Organon filing for Perjeta (pertuzumab) biosimilar candidate HLX11
28 March 2025 - -Shanghai Henlius Biotech and Organon today announced that the EMA has validated the marketing authorisation application for ...
Posted by Michael Wonder on 30 Mar 2025
Bristol Myers Squibb receives positive CHMP opinion for peri-operative regimen of neo-adjuvant Opdivo (nivolumab) and chemotherapy followed by surgery and adjuvant Opdivo for resectable non-small cell lung cancer in patients with tumour cell PD-L1 expression ≥1%
28 March 2025 - Recommendation based on Phase 3 CheckMate -77T trial showing significant event-free survival improvement when compared to neoadjuvant ...
Posted by Michael Wonder on 28 Mar 2025
Crinetics Pharmaceuticals announces EMA validation of marketing authorisation application and orphan drug designation for paltusotine in acromegaly
27 March 2025 - Crinetics Pharmaceuticals today announced that the EMA has validated the marketing authorisation application for paltusotine, the ...
Posted by Michael Wonder on 28 Mar 2025
Richter announces submission to EMA for biosimilar tocilizumab in multiple indications
27 March 2025 - Gedeon Richter announces today that the EMA has accepted Richter’s marketing authorisation application for its proposed biosimilar ...
Posted by Michael Wonder on 28 Mar 2025
Neurim Pharmaceuticals receives European marketing authorisation for paediatric prolonged-release melatonin (Slenyto) for the treatment of insomnia in children with ADHD
26 March 2025 - Neurim Pharmaceuticals announces that the European Commission has approved the extension of the indication to include ...
Posted by Michael Wonder on 27 Mar 2025
EMA publishes agenda for 24-27 March 2025 CHMP meeting
24 March 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 27 Mar 2025
European Commission approves Merck’s Capvaxive (pneumococcal 21 valent conjugate vaccine) for prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults
26 March 2025 - EC decision marks the fourth approval for Capvaxive for pneumococcal vaccination in adults ...
Posted by Michael Wonder on 26 Mar 2025
FDA grants priority review for biologics license application and EMA accepts marketing authorisation application for apitegromab as a treatment for spinal muscular atrophy
25 March 2025 - FDA to review BLA application under priority review, with a PDUFA date of 22 September 2025. ...
Posted by Michael Wonder on 25 Mar 2025
GSK’s application to expand use of Nucala (mepolizumab) for the treatment of COPD accepted for review by the European Medicines Agency
24 March 2025 - Submission based on data from MATINEE trial, which showed a statistically significant and clinically meaningful reduction in ...
Posted by Michael Wonder on 24 Mar 2025
CStone submits application to the EMA for new indication of sugemalimab in stage III non-small cell lung cancer
23 March 2025 - CStone Pharmaceuticals today announced the submission of a type II variation application to the EMA for sugemalimab. ...
Posted by Michael Wonder on 17 Mar 2025
Imfinzi approved in the EU as first and only immunotherapy for limited-stage small cell lung cancer
17 March 2025 - Approval based on ADRIATIC Phase 3 trial results which showed a 27% reduction in the risk ...
Posted by Michael Wonder on 17 Mar 2025
Bristol Myers Squibb receives approval from the European Commission to expand use of CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
14 March 2025 - In the TRANSCEND FL trial, 97.1% of patients responded to Breyanzi , with 94.2% of patients achieving ...
Posted by Michael Wonder on 12 Mar 2025
Geron announces European Commission approval of Rytelo (imetelstat), a first in class telomerase inhibitor, for the treatment of adults with transfusion-dependent anaemia due to lower risk MDS
11 March 2025 - Rytelo is the first and only telomerase inhibitor approved in the US and Europe. ...
Posted by Michael Wonder on 10 Mar 2025
Wainzua (eplontersen) approved in the EU for the treatment of hereditary transthyretin-mediated amyloidosis in adults with stage 1 or stage 2 polyneuropathy
10 March 2025 - Second major approval for Wainzua, which is marketed in the US as Wainua. ...
Posted by Michael Wonder on 07 Mar 2025
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma
7 March 2025 - Approval based on results of Phase 3 CheckMate-9DW clinical trial demonstrating a statistically significant and clinically ...