Blog
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 24 Oct 2025
FDA grants priority review for Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Padcev (enfortumab vedotin-ejfv), for certain patients with muscle-invasive bladder cancer
23 October 2025 - Applications based on Phase 3 KEYNOTE-905 results showing the combination improved event-free survival by 60%, reduced the ...
Posted by Michael Wonder on 24 Oct 2025
Biocon Biologics receives Health Canada spproval for Yesintek and Yesintek I.V. (ustekinumab), a biosimilar to Stelara
23 October 2025 - Biocon Biologics today announced that Health Canada has granted a notice of compliance for Yesintek (ustekinumab ...
Posted by Michael Wonder on 24 Oct 2025
Apotex receives Health Canada approval for Loqtorzi - the first and only immuno-therapy for recurrent unresectable or metastatic nasopharyngeal cancer
23 October 2025 - Apotex today announced that Health Canada has granted a notice of compliance for Loqtorzi (toripalimab) for ...
Posted by Michael Wonder on 23 Oct 2025
Heidelberg Pharma’s lead ADC candidate HDP-101 granted fast track designation by US FDA for the treatment of multiple myeloma
23 October 2025 - Heidelberg Pharma today announced that HDP-101 (pamlectabart tismanitin), the Company’s lead amanitin-based ADC candidate, has been ...
Posted by Michael Wonder on 23 Oct 2025
Zenocutuzumab-zbco granted FDA breakthrough therapy designation for NRG1 positive cholangiocarcinoma
23 October 2025 - Partner Therapeutics today announced that the US FDA has granted breakthrough therapy designation to zenocutuzumab-zbco for the ...
Posted by Michael Wonder on 23 Oct 2025
FDA grants fast track designation for AJ201, a first in class therapy for Kennedy's disease
23 October 2025 - AnnJi Pharmaceutical today announced that the US FDA has granted fast track designation for AJ201, the first ...
Posted by Michael Wonder on 23 Oct 2025
New ICER report shows significant jump in launch prices, exceeding inflation and GDP growth
23 October 2025 - Nearly $1.5 billion could have been saved in one year alone if prices matched ICER value ...
Posted by Michael Wonder on 23 Oct 2025
FDA approves belantamab mafodotin-blmf for relapsed or refractory multiple myeloma
23 October 2025 - Today, the FDA approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline), a B-cell maturation antigen (BCMA)-directed antibody and microtubule ...
Posted by Michael Wonder on 23 Oct 2025
New life saving medicine free for rare disease
22 October 2025 - Australians with the extremely rare and life-threatening inherited disease, acid sphingomyelinase deficiency (ASMD) will now have ...
Posted by Michael Wonder on 23 Oct 2025
Dupixent (dupilumab injection) approved in Canada for adults with inadequately controlled chronic obstructive pulmonary disease
22 October 2025 - Health Canada has approved Dupixent (dupilumab injection) as an add-on maintenance treatment in adult patients with chronic ...
Posted by Michael Wonder on 23 Oct 2025
Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) sBLA granted FDA priority review for treatment of certain patients with muscle-invasive bladder cancer
21 October 2025 - Results from the pivotal EV-303 trial demonstrated that, when used before and after surgery, the combination reduced ...
Posted by Michael Wonder on 23 Oct 2025
Electra Therapeutics receives FDA breakthrough therapy and EMA priority medicines designations for ELA026 in secondary haemophagocytic lymphohistiocytosis
22 October 2025 - Electra Therapeutics today announced that ELA026 has received US FDA breakthrough therapy designation and EMA Priority ...
Posted by Michael Wonder on 22 Oct 2025
Myosin Therapeutics receives FDA fast track designation for MT-125 in glioblastoma
22 October 2025 - Myosin Therapeutics today announced that the US FDA has granted fast track designation to MT-125 for the ...
Posted by Michael Wonder on 22 Oct 2025
Updated information about Pharmac’s priority lists (September 2025)
21 October 2025 - Pharmac’s Pūahoaho Report provides the latest information about applications for medicines, vaccines, and related products that we’ve ...
Posted by Michael Wonder on 22 Oct 2025
Sarilumab for the treatment of children/adolescents 2-17 years of age with polyarticular or oligoarticular juvenile idiopathic arthritis
22 October 2025 - NICE is unable to make a recommendation on the use of sarilumab (Kevzara) for the treatment of ...