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RSS FeedPosted by Michael Wonder on 03 Jun 2024
Zealand Pharma announces positive CHMP opinion for dasiglucagon for treatment of severe hypoglycemia in diabetes from European Medicines Agency
31 May 2024 - Zealand Pharma today announced that the CHMP of the EMA has issued a positive opinion recommending granting ...
Posted by Michael Wonder on 02 Jun 2024
Mirum Pharmaceuticals announces positive CHMP opinion for Livmarli (maralixibat) oral solution for the treatment of PFIC in patients three months of age and older
31 May 2024 - Positive opinion from CHMP based on Phase 3 MARCH study with highly statistically significant (p<0.0001) reduction in ...
Posted by Michael Wonder on 02 Jun 2024
Takeda receives positive CHMP opinion for recombinant ADAMTS13 (rADAMTS13) in congenital thrombotic thrombocytopenic purpura
31 May 2024 - Positive opinion based on totality of evidence, including results from the first randomised, controlled, cpen-label, cross-over Phase ...
Posted by Michael Wonder on 02 Jun 2024
Dupixent recommended for EU approval by the CHMP to treat patients with COPD
31 May 2024 - Recommendation for adults with uncontrolled chronic obstructive pulmonary disease with raised blood eosinophils based on data from ...
Posted by Michael Wonder on 02 Jun 2024
AbbVie receives positive CHMP opinion for risankizumab (Skyrizi) for the treatment of adults with moderately to severely active ulcerative colitis
31 May 2024 - The positive opinion is based on results from two pivotal Phase 3 trials, INSPIRE and COMMAND, that ...
Posted by Michael Wonder on 01 Jun 2024
New gene therapy treatment for haemophilia B
31 May 2024 - The EMA has recommended granting a conditional marketing authorisation in the European Union for Durveqtix (fidanacogene ...
Posted by Michael Wonder on 01 Jun 2024
First vaccine to protect adults from Chikungunya
31 May 2024 - EMA has recommended granting a marketing authorisation in the European Union for Ixchiq, the first vaccine ...
Posted by Michael Wonder on 31 May 2024
Highlights from the 27-30 May 2024 CHMP meeting
31 May 2024 - The EMA’s CHMP recommended 14 medicines for approval at its May 2024 meeting. ...
Posted by Michael Wonder on 31 May 2024
Annual report highlights progress in science, medicines and health in 2023
30 May 2024 - EMA’s annual report 2023 published today details the Agency’s contributions to public and animal health in the ...
Posted by Michael Wonder on 30 May 2024
European Commission adopts rules for joint clinical assessments
29 May 2024 - The European Commission has adopted joint clinical assessment rules detailing how national health care systems should ...
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 29 May 2024
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma
29 May 2024 - Approval based on results from CheckMate-901, the first Phase 3 trial in this patient population with an ...
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 27 May 2024
EMA publishes agenda for 27-30 May 2024 CHMP meeting
27 May 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
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 ...