Blog
RSS FeedPosted by Michael Wonder on 05 Jun 2024
Nidlegy marketing authorisation application submitted to EMA
4 June 2024 - First marketing authorisation submission for Nidlegy for the treatment of locally advanced, fully resectable melanoma in ...
Posted by Michael Wonder on 03 Jun 2024
Johnson & Johnson submits application to the EMA seeking approval of subcutaneous formulation of Rybrevant (amivantamab) for the treatment of patients with EGFR mutated non-small cell lung cancer
31 May 2024 - Submission is supported by data from the Phase 3 PALOMA-3 study featured at the American Society of ...
Posted by Michael Wonder on 30 May 2024
Vyluma announces marketing authorisation application validation for the European Union
29 May 2024 - Vyluma announced today that the EMA has validated the marketing authorisation application for its lead compound, NVK002. ...
Posted by Michael Wonder on 28 May 2024
Sarclisa accepted for FDA priority review for the treatment of transplant-ineligible newly diagnosed multiple myeloma
27 May 2024 - FDA priority review granted based on positive results from IMROZ Phase 3 study. ...
Posted by Michael Wonder on 25 May 2024
EMA validates Henlius and Organon filings for Prolia and Xgeva (denosumab) biosimilar candidate HLX14
24 May 2024 - Shanghai Henlius Biotech and Organon today announced that the EMA has validated the marketing authorisation applications for ...
Posted by Michael Wonder on 24 May 2024
Camurus receives EMA acceptance of MAA filing for octreotide SC depot (CAM2029) for the treatment of acromegaly
23 May 2024 - Camurus today announced that the EMA has accepted for review the company’s marketing authorisation application for octreotide ...
Posted by Michael Wonder on 06 May 2024
EMA validates Bristol Myers Squibb’s application 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
6 May 2024 - Application based on results from the CheckMate-8HW study, in which Opdivo plus Yervoy demonstrated statistically significant ...
Posted by Michael Wonder on 02 May 2024
Johnson & Johnson submits regulatory applications to EMA for Tremfya (guselkumab) for treatment of patients with ulcerative colitis and Crohn’s disease
1 May 2024 - Submission included data from the Phase 3 QUASAR program in ulcerative colitis and the Phase 3 GALAXI ...
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 04 Apr 2024
Rocket Pharmaceuticals announces EMA acceptance of RP-L102 marketing authorisation application for the treatment of Fanconi anaemia
2 April 2024 - Positive, previously disclosed results from the global Phase 1/2 trial demonstrated genetic and phenotypic correction combined ...
Posted by Michael Wonder on 03 Apr 2024
Autolus Therapeutics announces acceptance of marketing authorisation application by the EMA for obecabtagene autoleucel for patients with relapsed/refractory adult B-cell acute lymphoblastic leukaemia
2 April 2024 - Submission includes results from pivotal Phase 2 FELIX study evaluating obe-cel in r/r B-ALL. ...
Posted by Michael Wonder on 29 Mar 2024
PTC announces submission of sepiapterin MAA for treatment of PKU to EMA
28 March 2024 - First marketing authorisation submission for sepiapterin with additional global submissions to follow in 2024. ...
Posted by Michael Wonder on 27 Mar 2024
Norgine receives positive CHMP opinion recommending approval of NPJ5008 (dantrolene sodium hemiheptahydrate) for the treatment of malignant hyperthermia
26 March 2024 - Norgine today announced that the CHMP of the EMA has adopted a positive opinion recommending approval of ...
Posted by Michael Wonder on 07 Mar 2024
Johnson & Johnson submits application to the EMA for Darzalex (daratumumab)-based quadruplet therapy for the treatment of patients with transplant-eligible, newly diagnosed multiple myeloma
6 March 2024 - Submission supported by data from Phase 3 PERSEUS study, which showed the daratumumab subcutaneous formulation-based regimen significantly ...
Posted by Michael Wonder on 06 Mar 2024
CymaBay announces EMA accepts for review the marketing authorisation application for seladelpar for the treatment of primary biliary cholangitis
5 March 2024 - MAA validation follows recent applications for seladelpar to the UK MHRA and US FDA. ...