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 31 Jan 2024
Xtandi (enzalutamide) receives Health Canada approval as the first and only treatment for high risk patients with non-metastatic castration sensitive prostate cancer
30 January 2024 - Today, Astellas Pharma Canada announced that Health Canada has approved a supplemental new drug application for ...
Posted by Michael Wonder on 31 Jan 2024
GSK Canada's submission for momelotinib for the treatment of myelofibrosis accepted for review by Health Canada
30 January 2024 - GSK announces that Heath Canada has accepted into review the new drug submission for momelotinib, a potential ...
Posted by Michael Wonder on 30 Jan 2024
2024 PBS post-market review framework
31 January 2024 - The 2024 post-market review framework is now available. ...
Posted by Michael Wonder on 30 Jan 2024
Regulatory applications accepted in the US and Japan for Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) in relapsed or refractory follicular lymphoma and relapsed or refractory mantle cell lymphoma
30 January 2024 - US FDA grants both follicular lymphoma and mantle cell lymphoma applications priority review. ...
Posted by Michael Wonder on 30 Jan 2024
Pharma price cut proposals from US Government could be steep, analysts say
29 January 2024 - Pharmaceutical companies are due to receive by Thursday the US Government's opening proposal for what are ...
Posted by Michael Wonder on 30 Jan 2024
Ascidian Therapeutics announces fast tracks ACDN-01 in Stargardt disease and other ABCA4 retinopathies
29 January 2024 - Ascidian Therapeutics today announced that the US FDA has granted fast track ...
Posted by Michael Wonder on 30 Jan 2024
Treosulphan in combination with fludarabine phosphate before allogeneic stem cell transplantation for patients aged 1 month to 17 years with non-malignant diseases
30 January 2024 - NICE is unable to make a recommendation on the use of treosulphan (Trecondi) in combination with fludarabine ...
Posted by Michael Wonder on 30 Jan 2024
European Commission authorises GSK’s Omjjara (momelotinib)
29 January 2024 - Indicated in both newly diagnosed patients and those previously treated with existing standard of care. ...
Posted by Michael Wonder on 30 Jan 2024
Takeda’s Gammagard Liquid approved by US FDA for adults with chronic inflammatory demyelinating polyneuropathy
29 January 2024 - Approval supported by Phase 3 ADVANCE-CIDP open-label study data demonstrating safety and efficacy as an intravenous therapy ...
Posted by Michael Wonder on 30 Jan 2024
Takeda’s Hyqvia approved by European Commission as maintenance therapy in patients with chronic inflammatory demyelinating polyneuropathy
30 January 2024 - At home or in office administration provides CIDP patients with a personalised treatment experience. ...
Posted by Michael Wonder on 30 Jan 2024
GSK’s RSV vaccine, Arexvy, accepted for regulatory review by the EMA for the prevention of RSV disease in adults aged 50-59 at increased risk
29 January 2024 - Application supported by positive results of a Phase 3 trial showing immune response and acceptable tolerability ...
Posted by Michael Wonder on 29 Jan 2024
At 40, Medicare’s a marvel but it’s time for a health check
30 January 2024 - Big birthdays are a moment for reflection. And at 40, many of us need a check-up to ...
Posted by Michael Wonder on 29 Jan 2024
Will Medicare push drug prices down in 2024?
29 January 2024 - Medicare participants will get insight this year into how much the prices of certain drugs will ...
Posted by Michael Wonder on 29 Jan 2024
Merck, Johnson & Johnson CEOs agree to testify in Senate hearing on high drug prices
26 January 2024 - Bristol Myers Squibb CEO Chris Boerner and another unnamed pharmaceutical CEO accepted initial invitations to testify. ...
Posted by Michael Wonder on 29 Jan 2024
Rezzayo approved to treat adult patients with invasive candidiasis
29 January 2024 - The MHRA has today approved the medicine Rezzayo (rezafungin) to treat a fungal infection called invasive candidiasis. ...