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RSS FeedPosted by Michael Wonder on 25 May 2026
First medicine to treat rare uncontrolled growth of body tissues
22 May 2026 - Vijoice addresses an unmet medical need for patients with severe or life-threatening PIK3CA-related overgrowth spectrum disorders. ...
Posted by Michael Wonder on 25 May 2026
New medicine for two types of pulmonary fibrosis
22 May 2026 - Jascayd slowed loss of lung function in patients with idiopathic or progressive pulmonary fibrosis. ...
Posted by Michael Wonder on 25 May 2026
First oral GLP-1 treatment for weight management
22 May 2026 - EMA has recommended an extension to the marketing authorisation for Wegovy (semaglutide) in the EU to add ...
Posted by Michael Wonder on 25 May 2026
Henlius’ serplulimab receives positive CHMP opinion for the treatment of sqNSCLC
23 May 2026 - Henlius Biotech announced that serplulimab (Hetronifly), the company’s self-developed anti-PD-1 mAb, has received a positive opinion from ...
Posted by Michael Wonder on 21 May 2026
Allergan Aesthetics receives positive CHMP opinion for Boey (trenibotulinumtoxinE) for the temporary improvement of moderate to severe glabellar lines in adults
21 May 2026 - Positive opinion is supported by data from two pivotal Phase 3 trials, which demonstrated rapid results as ...
Posted by Michael Wonder on 20 May 2026
EMA publishes agenda for 18-21 May 2026 CHMP meeting
18 May 2026 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 25 Apr 2026
Highlights from 20-23 April 2026 CHMP meeting
24 April 2026 - The EMA’s CHMP recommended five medicines for approval at its April 2026 meeting. ...
Posted by Michael Wonder on 25 Apr 2026
Novartis receives positive CHMP opinion for Itvisma for spinal muscular atrophy
24 April 2026 - Novartis today announced that the CHMP of the EMA has adopted a positive opinion recommending marketing authorisation ...
Posted by Michael Wonder on 25 Apr 2026
Arrowhead Pharmaceuticals receives positive CHMP opinion recommending approval of Redemplo (plozasiran) to reduce triglycerides in adults with familial chylomicronaemia syndrome in Europe
24 April 2026 - The CHMP opinion is based on positive results from the Phase 3 PALISADE study where Redemplo ...
Posted by Michael Wonder on 25 Apr 2026
Sanofi’s Cenrifki (tolebrutinib) recommended for EU approval by the CHMP to treat secondary progressive multiple sclerosis without relapses
24 April 2026 - Recommendation based on the HERCULES phase 3 study which demonstrated that brain-penetrant Cenrifki (tolebrutinib) significantly delayed ...
Posted by Michael Wonder on 23 Apr 2026
EMA publishes agenda for 20-23 April 2026 CHMP meeting
20 April 2026 - The EMA has published a draft agenda for this week's CHMP meeting. ...
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 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 01 Mar 2026
EMA CHMP recommends EU approval of Henlius’ pertuzumab biosimilar HLX11
27 February 2026 - Shanghai Henlius Biotech announced that the CHMP of the EMA has adopted a positive opinion recommending the ...
Posted by Michael Wonder on 28 Feb 2026
Highlights from the 23-26 February 2026 CHMP meeting
27 February 2026 - The EMA’s CHMP has recommended 12 medicines for approval at its February 2026 meeting. ...