Blog
RSS FeedPosted by Michael Wonder on 27 Jul 2024
US FDA approves Leqselvi (deuruxolitinib), an oral JAK inhibitor for the treatment of severe alopecia areata
25 July 2024 - Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials. ...
Posted by Michael Wonder on 27 Jul 2024
Leo Pharma receives positive CHMP opinion of Anzupgo (delgocitinib cream) for the treatment of adults with moderate to severe chronic hand eczema
26 July 2024 - The positive opinion is based on results from the DELTA phase 3 program, which includes the randomised, ...
Posted by Michael Wonder on 27 Jul 2024
Update on regulatory review of lecanemab for early Alzheimer’s disease in the European Union
26 July 2024 - Eisai and Biogen announced today that the CHMP of the EMA has adopted a negative opinion ...
Posted by Michael Wonder on 27 Jul 2024
Ipsen receives CHMP positive opinions for Iqirvo (elafibranor) in primary biliary cholangitis and Kayfanda (odevixibat) in Alagille syndrome, two rare cholestatic liver diseases
26 July 2024 - Ipsen announced today two positive opinions by the EMA's CHMP for two different rare cholestatic liver disease ...
Posted by Michael Wonder on 27 Jul 2024
Astellas receives positive CHMP opinion for zolbetuximab in combination with chemotherapy for treatment of advanced gastric and gastro-oesophageal junction cancer
26 July 2024 - If approved by the European Commission, zolbetuximab would become the first and only CLDN18.2 targeted therapy approved ...
Posted by Michael Wonder on 27 Jul 2024
Astellas receives positive CHMP opinion for Padcev (enfortumab vedotin) in combination with Keytruda (pembrolizumab) for first-line treatment of advanced bladder cancer
26 July 2024 - Positive opinion is based on Phase 3 EV-302 clinical trial results which showed enfortumab vedotin in combination ...
Posted by Michael Wonder on 26 Jul 2024
AbbVie announces European Commission approval of Skyrizi (risankizumab) for the treatment of adults with moderately to severely active ulcerative colitis
26 July 2024 - The approval is supported by data from two pivotal Phase 3 trials: the INSPIRE induction trial and ...
Posted by Michael Wonder on 26 Jul 2024
Mirum’s Livmarli now approved for PFIC in patients 12 months and older
25 July 2024 - Mirum Pharmaceuticals today announced that the US FDA has approved a label expansion for Livmarli (maralixibat) oral ...
Posted by Michael Wonder on 26 Jul 2024
MHRA approves GLP-1 receptor agonist semaglutide to reduce risk of serious heart problems in obese or overweight adults
23 July 2024 - Semaglutide is the first weight loss drug approved in the UK as a preventative treatment for those ...
Posted by Michael Wonder on 26 Jul 2024
European Commission approves Pfizer’s Durveqtix (fidanacogene elaparvovec), a one-time gene therapy for adults with haemophilia B
25 July 2024 - A one-time dose of Durveqtix has reduced bleeds post-treatment compared to standard of care with a median ...
Posted by Michael Wonder on 26 Jul 2024
US FDA approves BioMarin's Brineura (cerliponase alfa) for children under 3 years with CLN2 disease
24 July 2024 - Now approved for children of all ages with CLN2 Batten disease, regardless of whether they yet ...
Posted by Michael Wonder on 25 Jul 2024
New clot busting drug recommended by NICE set to save NHS millions of pounds
24 July 2024 - Giving a new clot busting drug to people who have had a stroke could help save the ...
Posted by Michael Wonder on 25 Jul 2024
Health Canada grants full approval to Jemperli for the treatment of patients with recurrent or advanced dMMR/MSI-H endometrial cancer
24 July 2024 - The conversion of this indication from Notice of Compliance to full approval is based on long term ...
Posted by Michael Wonder on 24 Jul 2024
Voydeya approved in Canada as add-on therapy to ravulizumab or eculizumab for adults with the rare disease PNH who have residual haemolytic anaemia due to extravascular haemolysis
23 July 2024 - ALPHA Phase 3 trial showed first in class, oral, factor D inhibitor as add-on to Ultomiris ...
Posted by Michael Wonder on 23 Jul 2024
FDA approves Samsung Bioepis’ Epysqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab)
22 July 2024 - Epysqli is approved for the treatment of patients with paroxysmal nocturnal haemoglobinuria and atypical haemolytic uremic syndrome. ...