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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 19 Feb 2026
Pilatus Biosciences receives FDA fast track designation for metabolic checkpoint inhibitor PLT012 in hepatocellular carcinoma
19 February 2026 - Pilatus Biosciences today announced that the US FDA has granted fast track designation for PLT012, the ...
Posted by Michael Wonder on 19 Feb 2026
Garetosmab biologics license application accepted for FDA priority review for the treatment of fibrodysplasia ossificans progressiva
19 February 2026 - Regeneron Pharmaceuticals today announced that the US FDA has accepted for priority review the biologics license application ...
Posted by Michael Wonder on 19 Feb 2026
Enhertu type II variation application validated in the EU as post-neoadjuvant treatment for patients with HER2 positive early breast cancer
19 February 2026 - Based on DESTINY-Breast05 Phase 3 trial results, which showed Enhertu reduced the risk of invasive disease ...
Posted by Michael Wonder on 19 Feb 2026
Clinton's life could be cut short unless he pays thousands for PBS listed medication
18 February 2026 - After being diagnosed with a rare and aggressive form of thyroid cancer 10 years ago, father ...
Posted by Michael Wonder on 19 Feb 2026
ImmunityBio receives authorisation from the European Commission for Anktiva with BCG for non-muscle invasive bladder cancer carcinoma in situ, expanding global access to 33 countries
18 February 2026 - ImmunityBio today announced that the European Commission has granted conditional marketing authorisation for Anktiva (nogapendekin alfa inbakicept) ...
Posted by Michael Wonder on 18 Feb 2026
Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) receives US FDA breakthrough therapy designation for patients with advanced head and neck cancer
18 February 2026 - Johnson & Johnson today announced that the US FDA has granted breakthrough therapy designation for subcutaneous amivantamab ...
Posted by Michael Wonder on 18 Feb 2026
New Alzheimer’s drug won’t be covered by Dutch health insurance
18 February 2026 - A new drug for treating Alzheimer’s has only a marginal impact on people with the early ...
Posted by Michael Wonder on 18 Feb 2026
Novo’s Ozempic wins reimbursement in Korea but strict criteria limit early access
12 February 2026 - The entry of Novo Nordisk's GLP-1 receptor agonist Ozempic (semaglutide) into the Korean reimbursement market marks ...
Posted by Michael Wonder on 18 Feb 2026
Moderna announces the US FDA will initiate the review of its investigational seasonal influenza vaccine submission
18 February 2026 - Moderna has received a PDUFA goal date of 5 August 2026. ...
Posted by Michael Wonder on 18 Feb 2026
Moderna receives European Commission marketing authorisation for COVID-19 vaccine mNEXSPIKE
17 February 2026 - mNEXSPIKE is the third Moderna vaccine authorised in the European Union, strengthening the Company's respiratory vaccine ...
Posted by Michael Wonder on 18 Feb 2026
Harmony Biosciences receives US FDA approval for Wakix (pitolisant) for the treatment of cataplexy in paediatric narcolepsy
17 February 2026 - Harmony Biosciences today announced that the US FDA has approved its supplemental new drug application for Wakix ...
Posted by Michael Wonder on 18 Feb 2026
Sandoz receives US FDA approval to expand Enzeevu (aflibercept-abzv) label for multiple retinal indications
18 February 2026 - Sandoz today announced that the US FDA has approved an expanded label for Enzeevu (aflibercept-abzv), to include ...
Posted by Michael Wonder on 18 Feb 2026
Deciphera Pharmaceuticals announces US FDA acceptance for filing of new drug application for tirabrutinib in patients with relapsed or refractory PCNSL
17 February 2026 - Deciphera Pharmaceuticals today announced that the US FDA has accepted for filing the new drug application under ...
Posted by Michael Wonder on 18 Feb 2026
Biosimilar drug poses new test for Medicare price negotiations
12 February 2026 - A drug selected for the latest round of Medicare drug price negotiations stands to get dropped ...
Posted by Michael Wonder on 18 Feb 2026
Health Canada approves Keytruda SC, a subcutaneous formulation of pembrolizumab across multiple cancer indications
17 February 2026 - Merck announced today that Health Canada has approved Keytruda SC (pembrolizumab injection), a new subcutaneous formulation of ...