Blog
RSS FeedPosted by Michael Wonder on 18 Mar 2026
Patients to get new medicines up to six months sooner
17 March 2026 - Patients in England are set to receive some new medicines 3 to 6 months earlier under a ...
Posted by Michael Wonder on 05 Mar 2026
PDUFA action date for Hansa Biopharma's imlifidase BLA set for 19 December 2026
4 March 2026 - If approved, imlifidase will be the first treatment to address highly sensitised patients awaiting kidney transplantation. ...
Posted by Michael Wonder on 12 Feb 2026
Sick Australians risk being locked out of lifesaving medicines by outdated PBS
12 February 2026 - More medicines are successfully treating illness and disease, but Pfizer’s local boss says the PBS is falling ...
Posted by Michael Wonder on 11 Feb 2026
Canadians wait, on average, more than 65 weeks longer for access to new medicines than Europeans and 90 weeks more than Americans
10 February 2025 - Canadian patients are waiting, on average, more than 65 weeks longer than Europeans and over 90 ...
Posted by Michael Wonder on 30 Jan 2026
Canadians wait too long for access to innovative drugs, cautions the MEI
29 January 2026 - Pharmaceutical innovation is responsible for up to 66% of the increase in the age of death ...
Posted by Michael Wonder on 26 Jan 2026
Patient organisations welcome approval of six life-extending cancer treatments through Ontario's FAST Program, urge national expansion
23 January 2026 - Leading patient organisations are welcoming Ontario's announcement that six cancer drugs are now being fast-tracked for ...
Posted by Michael Wonder on 26 Jan 2026
AstraZeneca's Tagrisso and Calquence among first oncology treatments granted accelerated access through Ontario's FAST Program
23 January 2026 - AstraZeneca Canada is pleased to announce that Tagrisso (osimertinib) and Calquence (acalabrutinib tablets) are now publicly funded ...
Posted by Michael Wonder on 19 Jan 2026
Early access to supposedly innovative medicines: for a more informed bet
19 December 2025 - The evaluation of early access requests for medicines inherently involves a degree of uncertainty. Indeed, it relies ...
Posted by Michael Wonder on 17 Jan 2026
Some drugmakers quietly concerned about legal risk with speedy FDA review program
16 January 2026 - More than half a dozen major drug makers are participating in the Trump Administration's speedier review ...
Posted by Michael Wonder on 17 Jan 2026
US FDA delays two drug reviews in new voucher program after safety, efficacy concerns
15 January 2026 - The US FDA has delayed reviews of two drugs chosen for the Trump Administration's new fast ...
Posted by Michael Wonder on 16 Jan 2026
FDA reports lack of interest, high rejection rate for its STAR program
15 January 2026 - The US FDA said there is "minimal industry interest" from companies to participate in its Split ...
Posted by Michael Wonder on 14 Jan 2026
Travere Therapeutics announces FDA extends review of sNDA for Filspari (sparsentan) in FSGS
13 January 2026 - Travere Therapeutics announced that today the US FDA has extended the review timeline of its supplemental new ...
Posted by Michael Wonder on 24 Dec 2025
Sanofi provides update on tolebrutinib regulatory submission in non-relapsing secondary progressive multiple sclerosis
24 December 2025 - The US FDA has issued a complete response letter for the new drug application of tolebrutinib ...
Posted by Michael Wonder on 16 Dec 2025
Aldeyra Therapeutics announces PDUFA extension of the new drug application of reproxalap for the treatment of dry eye disease
15 December 2025 - Aldeyra Therapeutics today announced that the US FDA has extended the PDUFA target action date for the ...
Posted by Michael Wonder on 08 Dec 2025
Agios provides update on US sNDA for mitapivat in thalassaemia
8 December 2025 - Agios Pharmaceuticals today announced that the US FDA has not yet issued a regulatory decision on the ...