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RSS FeedPosted by Michael Wonder on 19 Nov 2025
Agenda for the March 2026 PBAC meeting (19 November 2025)
19 November 2025 - The agenda for the March 2026 PBAC meeting is now available. ...
Posted by Michael Wonder on 19 Nov 2025
European Commission approves Brinsupri (brensocatib) as the first and only treatment approved for non-cystic fibrosis bronchiectasis in the European Union
18 November 2025 - Brinsupri was reviewed under EMA's accelerated assessment pathway as it is considered of major interest for public ...
Posted by Michael Wonder on 18 Nov 2025
Vasa Therapeutics granted FDA fast track designation for VS-041, a novel investigational treatment of heart failure with preserved ejection fraction
18 November 2025 - Vasa Therapeutics today announced that the US FDA has granted fast track designation to its lead investigational ...
Posted by Michael Wonder on 18 Nov 2025
Arrowhead Pharmaceuticals announces FDA approval of Redemplo (plozasiran) to reduce triglycerides in adults with familial chylomicronaemia syndrome
18 November 2025 - The FDA approval is based on positive results from the Phase 3 PALISADE study where Redemplo significantly ...
Posted by Michael Wonder on 18 Nov 2025
FDA approves epcoritamab-bysp for follicular lymphoma indications
18 November 2025 - Today, the FDA approved epcoritamab-bysp (Epkinly, Genmab) with lenalidomide and rituximab for relapsed or refractory follicular ...
Posted by Michael Wonder on 18 Nov 2025
Lupron Depot new strength receives Health Canada approval for the treatment of advanced prostate cancer
17 November 2025 - AbbVie announced today that a new 6 month 45 mg Lupron Depot (leuprolide acetate for extended release ...
Posted by Michael Wonder on 18 Nov 2025
Henlius and Organon announce US FDA approval of Poherdy (pertuzumab-dpzb), the first Perjeta (pertuzumab) biosimilar in the US
17 November 2025 - Shanghai Henlius Biotech and Organon today announced that the US FDA has approved the biologics license application ...
Posted by Michael Wonder on 17 Nov 2025
Celcuity announces completion of submission of its new drug application to the US FDA for gedatolisib in HR+/HER2-/PIK3CA wild type advanced breast cancer
17 November 2025 - Celcuity today announced the completion of the submission of its new drug application to the US FDA ...
Posted by Michael Wonder on 17 Nov 2025
FDA grants fast track designation to Dewpoint Therapeutics’ DPTX3186 for the treatment of gastric cancer
17 November 2025 - Dewpoint Therapeutics announced today that the US FDA has granted fast track designation to DPTX3186, the company’s ...
Posted by Michael Wonder on 15 Nov 2025
Highlights from the 10-13 November 2025 CHMP meeting
14 November 2025 - The EMA’s CHMP recommended ten medicines for approval at its November 2025 meeting. ...
Posted by Michael Wonder on 15 Nov 2025
Sanofi’s Teizeild recommended for EU approval by the CHMP for patients with stage 2 type 1 diabetes
14 November 2025 - The EMA’s CHMP has adopted a positive opinion recommending the approval of Teizeild (teplizumab) to delay ...
Posted by Michael Wonder on 14 Nov 2025
Outcome statement - DUSC October 2025 meeting
14 November 2025 - The outcome statement from the October 2025 DUSC meeting is now available. ...
Posted by Michael Wonder on 14 Nov 2025
Public Summary Documents (first time decisions not to recommend and deferrals) – July 2025 PBAC meeting
14 November 2025 - The Public Summary Documents (first time decisions not to recommend and deferrals) from the July 2025 PBAC ...
Posted by Michael Wonder on 14 Nov 2025
Outlook Therapeutics announces acceptance of biologics license application by FDA for ONS-5010 as a treatment for wet AMD
13 November 2025 - Outlook Therapeutics today announced that the US FDA has acknowledged receipt of the resubmission of the ...
Posted by Michael Wonder on 14 Nov 2025
Arcutis Canada announces Health Canada approval of Zorvye 0.3% topical foam, the first steroid-free topical foam for scalp and body psoriasis, for adults and adolescents ages 12 and older
13 November 2025 - Approval supported by pivotal Phase 3 and Phase 2 data demonstrating rapid improvement in skin clearance and ...