Blog
RSS FeedPosted by Michael Wonder on 25 Mar 2024
US FDA approves Opsynvi (macitentan and tadalafil) as the first and only once daily single tablet combination therapy for patients with pulmonary arterial hypertension
22 March 2024 - Approval is based on the results from the pivotal Phase 3 A DUE study, which met ...
Posted by Michael Wonder on 25 Mar 2024
US FDA approves broad new labels for Esperion’s Nexletol and Nexlizet to prevent heart attacks and cardiovascular procedures in both primary and secondary prevention patients, regardless of statin use
22 March 2024 - Esperion today announced that the US FDA has approved broad new label expansions for Nexletol (bempedoic acid) ...
Posted by Michael Wonder on 24 Mar 2024
Highlights from the 18-21 March 2024 CHMP meeting
22 March 2024 - The EMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its March 2024 meeting. ...
Posted by Michael Wonder on 23 Mar 2024
Deliberations at the CHMP regarding the marketing authorisation application in the EU for lecanemab have been rescheduled due to procedural reasons at the EMA
22 March 2024 - Eisai announced today that the oral explanation scheduled for 19 March at the CHMP for lecanemab, ...
Posted by Michael Wonder on 23 Mar 2024
FDA approves mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer
22 March 2024 - Today, the FDA approved mirvetuximab soravtansine-gynx (Elahere, ImmunoGen) for adult patients with FRα positive, platinum-resistant epithelial ...
Posted by Michael Wonder on 22 Mar 2024
Astellas receives positive CHMP opinion for Xtandi in additional recurrent early prostate cancer treatment setting
22 March 2024 - If approved, XTANDI would become the first and only NHT treatment available for metastatic and high risk ...
Posted by Michael Wonder on 22 Mar 2024
Outlook Therapeutics receives European Union positive CHMP opinion for ONS-5010 as a treatment for wet AMD
22 March 2024 - Positive opinion serves as a basis for final decision for potential authorisation from the European Commission ...
Posted by Michael Wonder on 22 Mar 2024
Novartis Fabhalta (iptacopan) receives positive CHMP opinion as first oral monotherapy for adult patients with paroxysmal nocturnal hemoglobinuria
22 March 2024 - Positive CHMP opinion based on robust Phase III data, including APPLY-PNH, demonstrating superior haemoglobin improvement in the ...
Posted by Michael Wonder on 22 Mar 2024
Awiqli (once-weekly basal insulin icodec) recommended for approval for the treatment of diabetes by the European regulatory authorities
21 March 2024 - Novo Nordisk today announced that the European Medicines Agency’s CHMP has adopted a positive opinion, recommending ...
Posted by Michael Wonder on 22 Mar 2024
UCB receives positive CHMP opinion for Bimzelx (bimekizumab) for the treatment of adults with moderate to severe hidradenitis suppurativa
22 March 2024 - Positive CHMP opinion is supported by data from the two Phase 3 studies, BE HEARD I ...
Posted by Michael Wonder on 22 Mar 2024
Lisata Therapeutics announces US FDA rare paediatric disease designation granted to LSTA1 for the treatment of osteosarcoma
21 March 2024 - Lisata Therapeutics today announced that the US FDA has granted rare paediatric disease designation to LSTA1, the ...
Posted by Michael Wonder on 21 Mar 2024
FDA approves non-steroidal treatment for Duchenne muscular dystrophy
21 March 2024 - Today, the US FDA approved Duvyzat (givinostat) oral medication for the treatment of Duchenne muscular dystrophy in ...
Posted by Michael Wonder on 21 Mar 2024
Health Canada accepts for review new drug submission for tofersen for treatment of rare, genetic form of ALS
19 March 2024 - Health Canada regulatory decision on tofersen new drug submission expected in early 2025. ...
Posted by Michael Wonder on 21 Mar 2024
Ferinject approved by Health Canada for the treatment of iron deficiency anaemia in adult and paediatric patients and iron deficiency in adult patients with heart failure
19 March 2024 - CSL Vifor today announced that Health Canada has authorised Ferinject (ferric carboxymaltose) for the intravenous treatment of ...
Posted by Michael Wonder on 20 Mar 2024
Phanes Therapeutics' PT886 granted fast track designation for the treatment of patients with metastatic claudin 18.2 positive pancreatic adenocarcinoma by the FDA
20 March 2024 - Phanes Therapeutics announced today that the US FDA has granted fast track designation to PT886 for the ...