Blog
RSS FeedPosted by Michael Wonder on 14 Jul 2025
Astellas Korea renews bid to reimburse targeted gastric cancer drug Vyloy
11 July 2025 - Astellas Korea will reapply for health insurance coverage for its new drug Vyloy (zolbetuximab), a targeted ...
Posted by Michael Wonder on 13 Jul 2025
Zanubrutinib for the treatment of patients with relapsed or refractory mantle cell lymphoma
10 July 2025 - NICE has published final evidence-based recommendations on the use of zanubrutinib for the treatment of adults ...
Posted by Michael Wonder on 11 Jul 2025
Swissmedic approves Ifinwil (eflornithine) for children diagnosed with high-risk neuroblastoma
8 July 2025 - Norgine is pleased to announce that Swissmedic has approved the registration of Ifinwil (eflornithine) as monotherapy ...
Posted by Michael Wonder on 11 Jul 2025
FDA grants fast track designation for TRE-515 in combination with radiation therapy for the treatment of metastatic castration resistant prostate cancer
9 July 2025 - Trethera announced today that the US FDA has granted fast track designation for its novel drug, TRE-515, ...
Posted by Michael Wonder on 06 Jul 2025
MHRA approves nogapendekin alfa inbakicept to treat adult patients with non-muscle invasive bladder cancer
4 July 2025 - The MHRA has today approved nogapendekin alfa inbakicept (Anktiva) for adults with BCG unresponsive non-muscle invasive bladder ...
Posted by Michael Wonder on 04 Jul 2025
Imfinzi approved in the EU as first and only peri-operative immunotherapy for muscle-invasive bladder cancer
4 July 2025 - Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk ...
Posted by Michael Wonder on 04 Jul 2025
Jazz Pharmaceuticals receives European Commission marketing authorisation for Ziihera (zanidatamab) for the treatment of advanced HER2 positive biliary tract cancer
1 July 2025 - Conditional approval based on positive results from the HERIZON-BTC-01 Phase 2b trial. ...
Posted by Michael Wonder on 04 Jul 2025
Johnson & Johnson submits application to the EMA seeking indication extension of Akeega (niraparib and abiraterone acetate dual action tablet) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer and HRR gene alterations
3 July 2025 - The submission is based on results from the Phase 3 AMPLITUDE study evaluating niraparib in combination with ...
Posted by Michael Wonder on 03 Jul 2025
FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
2 July 2025 - Today, the FDA granted accelerated approval to sunvozertinib (Zegfrovy, Dizal) for adult patients with locally advanced ...
Posted by Michael Wonder on 02 Jul 2025
Life-saving breast cancer drug now cheaper thanks to expansion of the PBS
1 July 2025 - A potentially life-saving treatment for early-stage breast cancer will become much more affordable for hundreds of ...
Posted by Michael Wonder on 02 Jul 2025
Adagrasib for adults with previously treated, advanced, KRAS G12C mutation positive non-small-cell lung cancer
2 July 2025 - NICE is unable to make a recommendation on the use of adagrasib (Krazati) for the second-line treatment ...
Posted by Michael Wonder on 27 Jun 2025
Schrödinger receives fast track designation for SGR-1505 for the treatment of relapsed/refractory Waldenström's macroglobulinemia
27 June 2025 - Demonstrates the potential of SGR-1505 as a novel approach for diseases with high unmet medical need. ...
Posted by Michael Wonder on 27 Jun 2025
Xtandi (enzalutamide) now funded in Ontario for all approved prostate cancer indications
26 June 2025 - Today, Astellas Pharma Canada announced that Xtandi (enzalutamide) is now funded by the Ontario Drug Benefit Program ...
Posted by Michael Wonder on 26 Jun 2025
BeOne Medicines receives positive CHMP opinion for tablet formulation of Brukinsa
25 June 2025 - BeOne Medicines today announced that the CHMP of the EMA issued a positive opinion recommending approval ...
Posted by Michael Wonder on 24 Jun 2025
Revolution Medicines announces FDA breakthrough therapy designation for daraxonrasib in previously treated metastatic pancreatic cancer with KRAS G12 mutations
23 June 2025 - Breakthrough therapy designation based on promising early clinical evidence observed with daraxonrasib in patients with pancreatic ductal ...