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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 16 Jan 2026
Inside a clinic as Alzheimer’s patients and families gamble on controversial and costly new drugs
16 January 2026 - What price would you pay for the chance of just a little more quality time with a ...
Posted by Michael Wonder on 16 Jan 2026
FDA issues guidance on modernising statistical methods for clinical trials
12 January 2026 - The US FDA today published draft guidance designed to facilitate the use of Bayesian methodologies in ...
Posted by Michael Wonder on 15 Jan 2026
PBS prescription medicines more affordable for Australians
13 January 2026 - The Australian Government has launched a new advertising campaign to raise awareness about changes to maximum patient ...
Posted by Michael Wonder on 15 Jan 2026
Ontario pioneers access to treatment for severe alopecia areata with Lilly's Olumiant
14 January 2026 - Eli Lilly Canada announced today that Ontario leads the way as the first province to add Olumiant ...
Posted by Michael Wonder on 14 Jan 2026
TGA approves registration of lenacapavir for pre-exposure prophylaxis for HIV (Yeytuo)
9 January 2026 - On 17 December 2025, the TGA made the decision to approve the registration of lenacapavir (Yeytuo). ...
Posted by Michael Wonder on 14 Jan 2026
Sandoz confirms European Commission approval of Ondibta (insulin glargine), strengthening overall biosimilars leadership and position in diabetes
14 January 2026 - Expected launch by early 2027; potential to expand access to insulin treatment option for tens of millions ...
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 14 Jan 2026
Henlius' fifth US filing product bevacizumab biosimilar HLX04 receives FDA BLA acceptance
13 January 2026 - Shanghai Henlius Biotech announced that the biologics license application for HLX04, the Company’s independently developed bevacizumab biosimilar ...
Posted by Michael Wonder on 14 Jan 2026
FDA confirms a PDUFA goal date of 30 August 2026 for the sBLA submission of ropeginterferon alfa-2b-njft in essential thrombocythemia
13 January 2026 - PharmaEssentia today announced that the US FDA has accepted the Company’s supplemental biologics license application for ropeginterferon ...
Posted by Michael Wonder on 14 Jan 2026
Affordable eczema drug Dupixent still out of reach for children
14 January 2026 - Children under 12 with severe eczema face $20,000 yearly costs for life changing treatment despite medical experts ...
Posted by Michael Wonder on 14 Jan 2026
argenx announces FDA acceptance of supplemental biologics license application with priority review for Vyvgart in AChR-Ab seronegative gMG
13 January 2026 - argenx today announced that the US FDA has accepted for priority review a supplemental biologics license application ...
Posted by Michael Wonder on 14 Jan 2026
Bimzelz (bimekizumab injection) approved in Canada for treatment of moderate to severe hidradenitis suppurativa
13 January 2026 - The approval is based on clinically significant results from UCB's two pivotal Phase 3 trials demonstrating ...
Posted by Michael Wonder on 14 Jan 2026
US FDA grants Ipsen’s IPN60340 (ICT01) breakthrough therapy designation in first line unfit acute myeloid leukaemia
13 January 2025 - Ipsen announced today that the US FDA has granted breakthrough therapy designation for IPN60340 in combination with ...
Posted by Michael Wonder on 13 Jan 2026
Summit Therapeutics announces submission of biologics license application to US FDA seeking approval for ivonescimab in combination with chemotherapy in second-line (or later) treatment of patients with EGFRm NSCLC
12 January 2026 - Summit Therapeutics today announced that it has submitted a biologics license application to the US FDA seeking ...
Posted by Michael Wonder on 13 Jan 2026
Health Canada approves Rybelsus (semaglutide tablets) to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes
12 January 2026 - The indication expansion is based on positive outcomes observed in the cardiovascular outcomes (SOUL) trial data, ...