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RSS FeedPosted by Michael Wonder on 28 Mar 2026
Johnson & Johnson’s Darzalex (daratumumab) becomes the first oncology injectable approved for administration by patients or caregivers
27 March 2026 - Johnson & Johnson today announced that the CHMP of the EMA has granted approval for a Type ...
Posted by Michael Wonder on 28 Mar 2026
Sanofi’s Sarclisa subcutaneous formulation administered via on body injector recommended for EU approval by the CHMP to treat multiple myeloma
27 March 2026 - Recommendation based on positive results demonstrating comparable efficacy, pharmacokinetics, and safety of Sarclisa regimens administered subcutaneously compared ...
Posted by Michael Wonder on 28 Mar 2026
Richter receives European Commission approval for Fylrevy (estetrol tablet) as hormonal replacement therapy
27 March 2026 - Gedeon Richter announces today that the European Commission granted approval for the marketing authorisation of Fylrevy (estetrol; ...
Posted by Michael Wonder on 26 Mar 2026
UCB receives positive CHMP opinion for new Zilbrysq (zilucoplan) pre-filled pen in EU for adults living with generalised myasthenia gravis
26 March 2026 - UCB today announced that the CHMP of the EMA has issued a positive opinion recommending a ...
Posted by Michael Wonder on 20 Mar 2026
Bristol Myers Squibb transforms the classical Hodgkin lymphoma treatment paradigm with expanded US and EMA approvals for Opdivo (nivolumab)
20 March 2026 - Bristol Myers Squibb today announced that Opdivo (nivolumab) has received approval for two new classical Hodgkin ...
Posted by Michael Wonder on 16 Mar 2026
Imfinzi approved in the EU as first and only peri-operative immunotherapy for patients with early gastric and gastro-oesophageal cancers
16 March 2026 - Approval based on MATTERHORN Phase 3 trial demonstrating statistically significant and clinically meaningful improvements in event-free ...
Posted by Michael Wonder on 08 Mar 2026
Incyte announces the European Commission approval of Zynyz (retifanlimab) for the first-line treatment of advanced squamous cell carcinoma of the anal canal
6 March 2026 - The EC approval is based on results of the POD1UM-303 study which showed that adult patients with ...
Posted by Michael Wonder on 01 Mar 2026
EMA CHMP recommends EU approval of Henlius’ pertuzumab biosimilar HLX11
27 February 2026 - Shanghai Henlius Biotech announced that the CHMP of the EMA has adopted a positive opinion recommending the ...
Posted by Michael Wonder on 28 Feb 2026
Highlights from the 23-26 February 2026 CHMP meeting
27 February 2026 - The EMA’s CHMP has recommended 12 medicines for approval at its February 2026 meeting. ...
Posted by Michael Wonder on 27 Feb 2026
Lilly's Olumiant (baricitinib) recommended by CHMP for approval of expanded use in the European Union for adolescents with severe alopecia areata
27 February 2026 - Eli Lilly and Incyte announced today that the EMA's CHMP has issued a positive opinion for Olumiant ...
Posted by Michael Wonder on 27 Feb 2026
Dupixent (dupilumab) recommended for EU approval to treat chronic spontaneous urticaria in young children with ongoing symptoms despite treatment
27 February 2026 - Regeneron Pharmaceuticals and Sanofi today announced that the EMA’s CHMP adopted a positive opinion recommending the approval ...
Posted by Michael Wonder on 27 Feb 2026
Novartis receives positive CHMP opinion for remibrutinib in chronic spontaneous urticaria
27 February 2026 - Novartis announced today that the CHMP of the EMA has adopted a positive opinion recommending marketing authorisation ...
Posted by Michael Wonder on 23 Feb 2026
Sandoz confirms European Commission approval for Ranluspec (ranibizumab)
23 February 2026 - Launch expected second half of 2026; potential to expand access to life-changing treatment option for European patients. ...
Posted by Michael Wonder on 21 Feb 2026
Aumorlertinib mesylate tablets approved in the EU as monotherapy
20 February 2026 - Hansoh Pharmaceutical is pleased to announce that, on 12 February 2026, aumolertinib mesylate tablets have been ...
Posted by Michael Wonder on 19 Feb 2026
ImmunityBio receives authorisation from the European Commission for Anktiva with BCG for non-muscle invasive bladder cancer carcinoma in situ, expanding global access to 33 countries
18 February 2026 - ImmunityBio today announced that the European Commission has granted conditional marketing authorisation for Anktiva (nogapendekin alfa inbakicept) ...