Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 01 Apr 2026
FDA approves first new molecular entity under National Priority Voucher Program
1 April 2026 - The US FDA today approved Foundayo (orforglipron), marking the fifth approval under the Commissioner's National Priority Voucher ...
Posted by Michael Wonder on 01 Apr 2026
Injection for more than a million people to help prevent heart attacks and strokes recommended
1 April 2026 - People who have had a heart attack, stroke, or serious circulation problem in their legs, and who ...
Posted by Michael Wonder on 01 Apr 2026
New Zealand Pharmaceutical Schedule - 1 April 2026
1 April 2026 - The April 2026 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 01 Apr 2026
Scholar Rock resubmits biologics license application to FDA for apitegromab for treatment of children and adults with spinal muscular atrophy
31 March 2026 - Apitegromab biologics license application resubmission includes Catalent Indiana (part of Novo Nordisk) and second US based fill ...
Posted by Michael Wonder on 01 Apr 2026
Henlius receives two positive CHMP opinions for serplulimab, advancing global regulatory progress
30 March 2026 - Shanghai Henlius Biotech today announced that its self-developed anti-PD-1 monoclonal antibody, serplulimab (trade name in Europe: Hetronifly), ...
Posted by Michael Wonder on 01 Apr 2026
Cheaper medicines for people fighting cancer and rare diseases
1 April 2026 - The Albanese Government is continuing to deliver cheaper medicines with Australians living with debilitating conditions including ...
Posted by Michael Wonder on 31 Mar 2026
Schedule of Pharmaceutical Benefits - 1 April 2026
1 April 2026 - The April 2026 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 31 Mar 2026
ICER publishes final evidence report on therapies for IgA nephropathy
31 March 2026 - Independent appraisal committee found a net health benefit for sibeprenlimab, atacicept, and Nefecon. ...
Posted by Michael Wonder on 31 Mar 2026
European Commission approves Kygevi (doxecitine and doxribtimine) as first and only treatment for thymidine kinase 2 deficiency
31 March 2026 – UCB today announced that the European Commission has granted marketing authorisation under exceptional circumstances for Kygevi ...
Posted by Michael Wonder on 31 Mar 2026
Savara announces EMA validation of marketing authorisation application for Molbreevi in auto-immune pulmonary alveolar proteinosis
30 March 2026 - Savara today announced that the EMA has validated the submission of the Molbreevi marketing authorisation application ...
Posted by Michael Wonder on 31 Mar 2026
BridgeBio submits NDA to FDA for BBP-418 for individuals living with LGMD2I/R9
30 March 2026 - Comprehensive submission includes interim Phase 3 FORTIFY data demonstrating BBP-418’s rapid, consistent treatment effect and favourable safety ...
Posted by Michael Wonder on 31 Mar 2026
EMA validates indication extension application for Tryngolza (olezarsen) for the treatment of severe hypertriglyceridaemia
30 March 2026 - Sobi today announced that the EMA has validated an indication extension application for Tryngolza (olezarsen) for ...
Posted by Michael Wonder on 31 Mar 2026
Praxis Precision Medicines announces FDA acceptance and priority review of new drug application for relutrigine in patients with SCN2A and SCN8A DEEs
30 March 2026 - Praxis Precision Medicines today announced that the US FDA has accepted for priority review its new ...
Posted by Michael Wonder on 31 Mar 2026
Teva gains biosimilar momentum with US FDA approval of Ponlimsi (denosumab-adet) and dual filing acceptance for biosimilar candidate to Xolair (omalizumab)
30 March 2026 - Teva Pharmaceutical Industries today announced three milestones in its biosimilar portfolio, demonstrating continued momentum in the ...
Posted by Michael Wonder on 31 Mar 2026
FDA approves new high dose regimen of Spinraza (nusinersen) for spinal muscular atrophy
30 March 2026 - The approval was anchored on data from the pivotal DEVOTE study that investigated the efficacy and safety ...