Blog
RSS FeedPosted 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 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 ...
Posted by Michael Wonder on 25 May 2024
Celltrion receives European Commission approval of Omlyclo (CT-P39), the first and only omalizumab biosimilar approved in Europe
23 May 2024 - The European Commission decision is based on clinical evidence, including results from a Phase 3 clinical trial ...
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 22 May 2024
Sandoz receives European Commission approval for Wyost and Jubbonti, the first and only biosimilars of denosumab in Europe
22 May 2024 - EC approval based on robust development program confirming that biosimilar matches reference medicine in terms of ...
Posted by Michael Wonder on 21 May 2024
Wugen announces RMAT and PRIME designations for WU-CART-007 to accelerate regulatory reviews
20 May 2024 - Researchers to present new Phase 2 data showing safety and anti-leukaemic activity with WU-CART-007 and additional new ...
Posted by Michael Wonder on 09 May 2024
Aspaveli (pegcetacoplan) approved in Europe for use among treatment naïve adult patients with PNH
8 May 2024 - Sobi today announced that the European Commission has approved an indication extension for Aspaveli (pegcetacoplan) for ...