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RSS FeedPosted by Michael Wonder on 11 Jun 2026
Italfarmaco announces Health Canada acceptance and priority review of new drug submission for givinostat as a Duchenne muscular dystrophy treatment
10 June 2026 - New drug submission is based on Italfarmaco’s Phase 3 EPIDYS trial data demonstrating meaningful treatment benefits ...
Posted by Michael Wonder on 12 Jun 2026
FDA grants priority review for Genentech’s Tecentriq for a certain type of stage III colon cancer
10 June 2026 - Genentech announced today that the US FDA has accepted the company’s supplemental biologics license application filing for ...
Posted by Michael Wonder on 12 Jun 2026
FDA approves belzutifan with pembrolizumab for adjuvant treatment of renal cell carcinoma
12 June 2026 - Today, the FDA approved belzutifan (Welireg, Merck) in combination with pembrolizumab (Keytruda, Merck) or pembrolizumab and ...
Posted by Michael Wonder on 12 Jun 2026
Truqap combination approved in the US as first and only targeted treatment for PTEN-deficient metastatic hormone-sensitive prostate cancer
12 June 2026 - Based on results of CAPItello-281 which prospectively defined PTEN deficient disease and showed Truqap combination reduced risk ...
Posted by Michael Wonder on 11 Jun 2026
Eli Lilly Canada welcome Quebec public reimbursement of Verzenio (abemaciclib) for mBC following successful PCPA negotiation
10 June 2026 - Eli Lilly Canada is pleased to announce that Verzenio (abemaciclib) is now publicly reimbursed in Québec ...
Posted by Michael Wonder on 11 Jun 2026
Zemcelpro (UM171 cell therapy) licensing and supply agreements announced for Canada
10 June 2026 - ExCellThera today announced exclusive licensing and supply agreements granting Medexus the Canadian commercialization rights for Zemcelpro ...
Posted by Michael Wonder on 11 Jun 2026
Slow process: 48 treatments awaiting approval in the Netherlands already used in Germany
10 June 2026 - The Netherlands takes much longer than other countries to give patients access to new medicines and ...
Posted by Michael Wonder on 11 Jun 2026
Update from the PBAC (May 2026)
11 June 2026 - The PBAC held a one day intracycle meeting on 8 May 2026. ...
Posted by Michael Wonder on 10 Jun 2026
EMA confirms asundexian marketing authorization application for assessment in secondary prevention of ischemic stroke
10 June 2026 - Bayer today announced that the EMA has positively validated and begun assessing the company’s marketing authorisation ...
Posted by Michael Wonder on 10 Jun 2026
Nipocalimab (Imaavy) authorised to treat adults and adolescents with generalised myasthenia gravis
9 June 2026 - The MHRA has today authorised the medicine nipocalimab (Imaavy) to treat adults and adolescents aged 12 years ...
Posted by Michael Wonder on 10 Jun 2026
Dutch drug reimbursement reform stalls despite rising patient waits
9 June 2026 - The Netherlands has postponed the launch of a revamped system for determining which new medicines will ...
Posted by Michael Wonder on 10 Jun 2026
RedHill's opaganib receives FDA rare paediatric disease designation for neuroblastoma in addition to current orphan drug designation
9 June 2026 - RedHill Biopharma today announced that the US FDA has granted rare pediatric disease designation to opaganib for ...
Posted by Michael Wonder on 10 Jun 2026
Matisse Pharmaceuticals receives FDA fast track designation for isupartob sodium in sepsis
9 June 2026 - Matisse Pharmaceuticals today announced that the US FDA has granted fast track designation for its lead compound ...
Posted by Michael Wonder on 10 Jun 2026
Imugene's azer-cel granted FDA fast track designation for CLL/SLL and MZL
9 June 2026 - Imugene is pleased to announce that the US FDA has granted fast track designation to azer-cel ...
Posted by Michael Wonder on 10 Jun 2026
Chiesi Global Rare Diseases announces Health Canada grants priority review for Filsuvez (birch triterpenes) topical gel for the treatment of epidermolysis bullosa
9 June 2026 - Chiesi Global Rare Diseases today announced that Health Canada has accepted the new drug submission for Filzuvez ...