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 10 Mar 2026
Koselugo approved in Canada for plexiform neurofibromas in adults with neurofibromatosis type 1
9 March 2026 - Approval based on KOMET Phase 3 trial results which showed 20% objective response rate in tumour ...
Posted by Michael Wonder on 10 Mar 2026
Chiesi Global Rare Diseases and Protalix BioTherapeutics announce European Commission approval of additional dosing regimen of every four weeks for Elfabrio (pegunigalsidase alfa)
9 March 2026 - Chiesi Global Rare Diseases and Protalix BioTherapeutics today announced that the European Commission has approved the 2 ...
Posted by Michael Wonder on 09 Mar 2026
Precision BioSciences receives FDA fast track sesignation for PBGENE-DMD
9 March 2026 - Precision BioSciences today announced that the US FDA has granted fast track designation to PBGENE-DMD for the ...
Posted by Michael Wonder on 09 Mar 2026
FDA takes further steps to streamline biosimilar development and make medicines more affordable
9 March 2026 - The US FDA today announced another major step in its initiative to streamline the development of biosimilar ...
Posted by Michael Wonder on 09 Mar 2026
ICER to assess treatment for Parkinson’s disease
9 March 2026 - Report will be subject of CTAF meeting in October 2026; draft scoping document open to public ...
Posted by Michael Wonder on 09 Mar 2026
Ipsen voluntarily withdraws Tazverik (tazemetostat) in follicular lymphoma and epithelioid sarcoma
9 March 2026 - Ipsen announced today that it is voluntarily withdrawing Tazverik (tazemetostat) in all indications from all Ipsen ...
Posted by Michael Wonder on 09 Mar 2026
Enhertu granted priority review in the US as post-neoadjuvant treatment for patients with HER2 positive early breast cancer
9 March 2026 - Based on DESTINY-Breast05 Phase 3 trial results, which showed Enhertu reduced the risk of invasive disease ...
Posted by Michael Wonder on 08 Mar 2026
Incyte announces the European Commission approval of Zynyz (retifanlimab) for the first-line treatment of advanced squamous cell carcinoma of the anal canal
6 March 2026 - The EC approval is based on results of the POD1UM-303 study which showed that adult patients with ...
Posted by Michael Wonder on 08 Mar 2026
Ottawa should allow all drugs approved in the EU and US to be marketed in Canada
7 March 2026 - The FederalGovernment plans to speed up some drug approvals in Canada by allowing Health Canada to ...
Posted by Michael Wonder on 07 Mar 2026
FDA official offers insights on agency’s criteria for real world data in regulatory submissions
6 March 2026 - The US FDA will consider several factors when determining whether to accept real world data and ...
Posted by Michael Wonder on 07 Mar 2026
US FDA approves Bristol Myers Squibb’s Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis
6 March 2026 - Significantly more patients treated with once daily, oral Sotyktu achieved an ACR20 response compared with placebo at ...
Posted by Michael Wonder on 07 Mar 2026
Lantheus announces FDA approval of Pylarify TruVu (piflufolastat F 18) injection
6 March 2026 - Pylarify TruVu is expected to launch in Q4, 2026, with a phased geographic rollout to support a ...
Posted by Michael Wonder on 07 Mar 2026
Trump’s drive to get Europe to pay more for drugs creates uncertainty for countries, patients
2 March 2026 - Pharma is also eager to see the region increase spending on medicines. ...
Posted by Michael Wonder on 06 Mar 2026
A month in, TrumpRx falls short of president’s grand promises
5 March 2026 - Few drugs, uneven savings mark early days of Trump’s discount medicines website. ...
Posted by Michael Wonder on 06 Mar 2026
Public summary documents – November 2025 PBAC meeting
6 March 2026 - The Public Summary Documents (positive recommendations and subsequent decisions not to recommend) from the November 2025 PBAC ...