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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 28 Mar 2026
Bepirovirsen accepted for review by the EMA as a potential first in class treatment for chronic hepatitis B
27 March 2026 - Submission supported by statistically significant and clinically meaningful functional cure rates in pivotal PhIII B-Well trials. ...
Posted by Michael Wonder on 27 Mar 2026
Eisai and Nuvation Bio announce marketing authorisation application for taletrectinib for the treatment of advanced ROS1 positive non-small cell lung cancer validated by the EMA
26 March 2026 - Additional filings are planned for the UK, Canada and other regions included in Eisai's licensed territories. ...
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 25 Mar 2026
Anavex Life Sciences provides update on regulatory review in the EU for blarcamesine to treat early Alzheimer’s disease
25 March 2026 - Anavex Life Sciences today announced that it has withdrawn its application for the marketing authorisation of ...
Posted by Michael Wonder on 23 Mar 2026
EMA publishes agenda for 23-26 March 2026 CHMP meeting
23 March 2026 - The EMA has published a draft agenda for this week's CHMP meeting. ...
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 16 Mar 2026
EMA proposes new paper on proof of concept studies for paediatric oncology drugs
13 March 2026 - The EMA has released a concept paper proposing a future reflection paper on the development of ...
Posted by Michael Wonder on 11 Mar 2026
Tecvayli (teclistamab) monotherapy application submitted to the EMA for relapsed/refractory multiple myeloma after at least one prior therapy
10 March 2026 - Johnson & Johnson today announced the submission of a type II variation application to the EMA seeking ...
Posted by Michael Wonder on 11 Mar 2026
Lenz Therapeutics announces submission of marketing authorisation application to the EMA for Vizz for the treatment of presbyopia
10 March 2026 - Lenz Therapeutics today announced that it has submitted a marketing authorisation application to the EMA for ...
Posted by Michael Wonder on 10 Mar 2026
Chiesi Global Rare Diseases and Protalix BioTherapeutics announce European Commission approval of additional dosing regimen of every four weeks for Elfabrio (pegunigalsidase alfa)
9 March 2026 - Chiesi Global Rare Diseases and Protalix BioTherapeutics today announced that the European Commission has approved the 2 ...
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 ...