Blog
RSS FeedPosted by Michael Wonder on 15 Jul 2025
New cystic fibrosis drug fast tracked for NHS use
15 July 2025 - Some people with cystic fibrosis are set to benefit from a new once daily triple therapy treatment, ...
Posted by Michael Wonder on 10 Jun 2025
Research funding and more treatment options to support the fight against MND
9 June 2025 - The Australian Government is providing a further $4.5 million and listing another treatment to ensure the ...
Posted by Michael Wonder on 10 Jun 2025
DoH publishes revised agenda for July 2025 PBAC meeting (version 4)
10 June 2025 - The DoH has published a revised agenda for next month's PBAC meeting. ...
Posted by Michael Wonder on 10 Jun 2025
Axsome Therapeutics provides update on the new drug application for AXS-14 for the management of fibromyalgia
9 June 2025 - Axsome Therapeutics today announced it has received a refusal to file letter from the US FDA ...
Posted by Michael Wonder on 10 Jun 2025
Alnylam receives European Commission approval for Amvuttra (vutrisiran) for the treatment of ATTR amyloidosis with cardiomyopathy
9 June 2025 - Decision follows recent authorisations in the US and Brazil. ...
Posted by Michael Wonder on 10 Jun 2025
US FDA approves Merck’s Enflonsia (clesrovimab-cfor) for prevention of respiratory syncytial virus lower respiratory tract disease in infants born during or entering their first RSV season
9 June 2025 - Enflonsia is the first and only RSV preventive option administered to infants using the same dose ...
Posted by Michael Wonder on 10 Jun 2025
Lipocine announces filing of new drug submission for Tlando in Canada
9 June 2025 - New drug submission filed by Lipocine's licensing partner Verity Pharma. ...
Posted by Michael Wonder on 09 Jun 2025
George Medicines announces FDA approval of Widaplik (telmisartan, amlodipine and indapamide), a new single pill combination treatment for hypertension in adults, including initial treatment
9 June 2025 - Commercialisation planning underway with US launch anticipated Q4, 2025. ...
Posted by Michael Wonder on 09 Jun 2025
SMC - June 2025 decisions
9 June 2025 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...
Posted by Michael Wonder on 07 Jun 2025
European Commission approves Duvyzat for the treatment of Duchenne muscular dystrophy
6 June 2025 - The approval is based on Phase 3 EPIDYS trial data that demonstrated meaningful treatment benefits in ambulant ...
Posted by Michael Wonder on 07 Jun 2025
BioCryst achieves reimbursement for Orladeyo across all major European countries
6 June 2025 - Orladeyo (berotralstat) now reimbursed in the Netherlands. ...
Posted by Michael Wonder on 06 Jun 2025
Arvinas announces submission of new drug application to US FDA for vepdegestrant for patients with ESR1 mutated ER+/HER2- advanced or metastatic breast cancer
6 June 2025 - Arvinas today announced the submission of a new drug application to the US FDA with its partner ...
Posted by Michael Wonder on 06 Jun 2025
Fixed-duration Calquence-based regimens approved in EU for patients with chronic lymphocytic leukaemia in the first-line setting
6 June 2025 - AMPLIFY Phase III trial results demonstrated statistically significant and clinically meaningful improvement in progression-free survival for ...
Posted by Michael Wonder on 06 Jun 2025
Merz Aesthetics receives approval from Health Canada for Radiesse as an aesthetic injectable for the treatment of moderate wrinkles in the décolleté area
5 June 2025 - Merz Aesthetics Canada announced today the Health Canada approval for Radiesse for the treatment of moderate ...
Posted by Michael Wonder on 06 Jun 2025
MSD Korea wins coverage boost for transplant infection drug Prevymis
4 June 2025 - MSD Korea has won expanded reimbursement for Prevymis (letermovir), extending coverage from 100 to 200 days ...
Posted by Michael Wonder on 06 Jun 2025
Biogen disappointed by INESSS recommendation on Skyclarys and its impact on Quebec patients with Friedreich ataxia
5 June 2025 - Biogen Canada is disappointed by INESSS's recommendation against listing Skyclarys (omaveloxolone), despite its therapeutic potential for ...