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RSS FeedPosted by Michael Wonder on 27 Apr 2024
Pierre Fabre Laboratories receive positive CHMP opinion for Obgemsa (vibegron) in overactive bladder syndrome
26 April 2024 - Pierre Fabre Laboratories announced that the CHMP of the EMA has adopted a positive opinion recommending approval ...
Posted by Michael Wonder on 27 Apr 2024
Takeda receives positive CHMP opinion for fruquintinib in previously treated metastatic colorectal cancer
26 April 2024 - If approved in the European Union, fruquintinib will be the first novel targeted therapy for metastatic colorectal ...
Posted by Michael Wonder on 27 Apr 2024
Johnson & Johnson receives positive CHMP opinion for Rybrevant (amivantamab) in combination with chemotherapy for the first-line treatment of patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations
26 April 2024 - The recommendation is supported by data from the Phase 3 PAPILLON study, which showed amivantamab plus chemotherapy ...
Posted by Michael Wonder on 27 Apr 2024
CHMP adopts positive opinion recommending approval of Bristol Myers Squibb’s Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma
26 April 2024 - Recommendation based on results from CheckMate-901, the first Phase 3 trial with an immunotherapy-chemotherapy combination to demonstrate ...
Posted by Michael Wonder on 26 Apr 2024
Vertex announces European Commission approval for Kalydeco to treat infants with cystic fibrosis ages 1 month and older
26 April 2024 - Kalydeco is the first and only medicine approved in the EU in this age group to ...
Posted by Michael Wonder on 25 Apr 2024
Travere Therapeutics and CSL Vifor announce European Commission approves Filspari (sparsentan) for the treatment of IgA nephropathy
24 April 2024 - Conditional marketing authorisation is based on statistically significant and clinically meaningful results from the Phase 3 ...
Posted by Michael Wonder on 24 Apr 2024
Averoa submits marketing authorisation application to the European Medicines Agency seeking approval of AVA1014 for treating complications associated with chronic kidney disease
23 April 2024 - Averoa announces the submission of a marketing authorisation application to the EMA for Ferric Citrate Coordination ...
Posted by Michael Wonder on 23 Apr 2024
Astellas' Xtandi (enzalutamide) granted European Commission approval for use in additional recurrent early prostate cancer treatment setting
23 April 2024 - Approval is based on results from the positive Phase 3 EMBARK study which showed Xtandi alone ...
Posted by Michael Wonder on 23 Apr 2024
Voydeya approved in the EU as add-on treatment to ravulizumab or eculizumab for adults with the rare disease PNH who have residual haemolytic anaemia
23 April 2024 - ALPHA Phase 3 trial showed first-in-class, oral, Factor D inhibitor as add-on to Ultomiris or Soliris ...
Posted by Michael Wonder on 23 Apr 2024
New recommendations to strengthen supply chains of critical medicines
23 April 2024 - EMA has published a number of recommendations to address vulnerabilities in the production and delivery of medicines ...
Posted by Michael Wonder on 23 Apr 2024
European Commission approves Pfizer’s Emblaveo for patients with multidrug-resistant infections and limited treatment options
22 April 2024 - Emblaveo was reviewed under EMA accelerated assessment procedure, used when a pharmaceutical product is of major ...
Posted by Michael Wonder on 22 Apr 2024
EMA publishes agenda for 22-25 April 2024 CHMP meeting
22 April 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 22 Apr 2024
Sandoz confirms European Commission approval of Pyzchiva (ustekinumab), further strengthening immunology offering
22 April 2024 - EC approval based on robust development program confirming match to reference medicine in terms of safety, ...
Posted by Michael Wonder on 22 Apr 2024
UCB receives European Commission approval for Bimzelx (bimekizumab) as the first IL-17A and IL-17F biologic for moderate to severe hidradenitis suppurativa
22 April 2024 - Approval is supported by data from two Phase 3 studies, BE HEARD I and BE HEARD ...
Posted by Michael Wonder on 08 Apr 2024
EMA says it will consider conditional approval for NASH drugs using intermediate outcomes
5 April 2024 - The EMA said in a new reflection paper that it will consider granting conditional marketing approval ...