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RSS FeedPosted by Michael Wonder on 08 Apr 2026
Apotex strengthens osteoporosis care in Canada with Health Canada's approval of Denoza, a denosumab biosimilar
7 April 2026 - Apotex today announced that Health Canada has approved Denoza (denosumab injection), a biosimilar to Prolia, for its ...
Posted by Michael Wonder on 08 Apr 2026
PBS listing of lamotrigine for bipolar disorder
8 April 2026 - At its November 2025 meeting, the PBAC recommended a new Restricted Benefit listing on the PBS ...
Posted by Michael Wonder on 07 Apr 2026
FDA approves first generic dapagliflozin tablets
7 April 2026 - FDA approves multiple generics of Farxiga. ...
Posted by Michael Wonder on 06 Apr 2026
Padcev, Tavneos clear key step toward reimbursement in Korea
3 April 2026 - Astellas Pharma Korea’s Padcev (enfortumab vedotin) for urothelial carcinoma and Meditip’s Tavneos (avacopan) for rare vasculitides ...
Posted by Michael Wonder on 04 Apr 2026
European Commission approves Keytruda (pembrolizumab) plus paclitaxel ± bevacizumab for the treatment of adults with PD-L1 (CPS ≥1) platinum-resistant recurrent ovarian carcinoma who have received one or two prior systemic treatment regimens
2 April 2026 - Merck announced that Keytruda (pembrolizumab), in combination with paclitaxel, with or without bevacizumab, is approved in the ...
Posted by Michael Wonder on 03 Apr 2026
Sevabertinib approved to treat adults with HER2 positive lung cancer that has spread or cannot be removed by surgery
2 April 2026 - The MHRA has approved sevabertinib (Hyrnuo) to treat adults with advanced non-small cell lung cancer with ...
Posted by Michael Wonder on 02 Apr 2026
Eylea HD (aflibercept) approved by FDA as first and only injectable anti-VEGF with dosing intervals up to 5 months for wet age-related macular degeneration and diabetic macular oedema
2 April 2026 - Regeneron Pharmaceuticals today announced that the US FDA has approved the extension of dosing intervals for Eylea ...
Posted by Michael Wonder on 01 Apr 2026
FDA approves Lilly's Foundayo (orforglipron), the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions
1 April 2026 - Foundayo, Lilly's second FDA approved obesity medicine, will be available via LillyDirect with free home delivery, ...
Posted by Michael Wonder on 01 Apr 2026
Vertex announces US FDA approval for label extensions of Alyftrek and Trikafta, expanding availability of these medicines to ~95% of all people with CF in the United States
1 April 2026 - Vertex Pharmaceuticals today announced the US FDA has approved expanded use of Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) for the ...
Posted by Michael Wonder on 01 Apr 2026
FDA approves first new molecular entity under National Priority Voucher Program
1 April 2026 - The US FDA today approved Foundayo (orforglipron), marking the fifth approval under the Commissioner's National Priority Voucher ...
Posted by Michael Wonder on 01 Apr 2026
Injection for more than a million people to help prevent heart attacks and strokes recommended
1 April 2026 - People who have had a heart attack, stroke, or serious circulation problem in their legs, and who ...
Posted by Michael Wonder on 01 Apr 2026
Henlius receives two positive CHMP opinions for serplulimab, advancing global regulatory progress
30 March 2026 - Shanghai Henlius Biotech today announced that its self-developed anti-PD-1 monoclonal antibody, serplulimab (trade name in Europe: Hetronifly), ...
Posted by Michael Wonder on 31 Mar 2026
ICER publishes final evidence report on therapies for IgA nephropathy
31 March 2026 - Independent appraisal committee found a net health benefit for sibeprenlimab, atacicept, and Nefecon. ...
Posted by Michael Wonder on 31 Mar 2026
European Commission approves Kygevi (doxecitine and doxribtimine) as first and only treatment for thymidine kinase 2 deficiency
31 March 2026 – UCB today announced that the European Commission has granted marketing authorisation under exceptional circumstances for Kygevi ...
Posted by Michael Wonder on 31 Mar 2026
Teva gains biosimilar momentum with US FDA approval of Ponlimsi (denosumab-adet) and dual filing acceptance for biosimilar candidate to Xolair (omalizumab)
30 March 2026 - Teva Pharmaceutical Industries today announced three milestones in its biosimilar portfolio, demonstrating continued momentum in the ...