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 11 Dec 2025
ICER releases draft evidence report on therapies for IgA nephropathy
10 December 2025 - Public comment period now open until 14 January 2026; Requests to make oral comment during public ...
Posted by Michael Wonder on 11 Dec 2025
US FDA grants priority review to Bristol Myers Squibb's application for Opdivo (nivolumab) plus chemotherapy combination for classical Hodgkin's lymphoma
11 December 2025 - Bristol Myers Squibb today announced that the US FDA has accepted and granted priority review to ...
Posted by Michael Wonder on 10 Dec 2025
FDA approves first gene therapy treatment for Wiskott-Aldrich syndrome
9 December 2025 - Agency exercises regulatory flexibility to address unmet need for rare, life-threatening disease. ...
Posted by Michael Wonder on 10 Dec 2025
First approval in Commissioner's National Priority Voucher Pilot Program strengthens domestic antibiotic manufacturing capacity
9 December 2025 - The US FDA today approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner's National Priority Voucher pilot program, ...
Posted by Michael Wonder on 10 Dec 2025
Senti Bio receives FDA regenerative medicine advanced therapy designation for SENTI-202 in the treatment of adults with relapsed or refractory acute myeloid leukaemia
9 December 2025 - Senti Biosciences today announced that the US FDA has granted regenerative medicine advanced therapy designation to ...
Posted by Michael Wonder on 10 Dec 2025
Biogen receives Health Canada authorisation for Zurzuvae (zuranolone), the first and only treatment indicated for adults with postpartum depression in Canada
9 December 2025 - Biogen Canada today announced that Health Canada has issued a Notice of Compliance for Zurzuvae (zuranolone) ...
Posted by Michael Wonder on 10 Dec 2025
FDA grants breakthrough therapy designation to investigational drug adrabetadex for individuals with infantile onset Niemann-Pick disease type C
9 December 2025 - Breakthrough therapy designation is based on FDA’s review of survival analyses comparing adrabetadex-treated patients with external ...
Posted by Michael Wonder on 09 Dec 2025
PBS safe, government vows after US-UK medicines deal to increase spending revealed
8 December 2025 - The Federal Government has vowed the PBS is not up for negotiation after it was revealed ...
Posted by Michael Wonder on 09 Dec 2025
Saskatchewan adds Capvaxive to publicly funded adult immunisation program
8 December 2025 - Merck announced today that the province of Saskatchewan has added Capvaxive, a 21 valent pneumococcal conjugate vaccine, ...
Posted by Michael Wonder on 08 Dec 2025
Agios provides update on US sNDA for mitapivat in thalassaemia
8 December 2025 - Agios Pharmaceuticals today announced that the US FDA has not yet issued a regulatory decision on the ...
Posted by Michael Wonder on 08 Dec 2025
EMA publishes agenda for 8-11 December 2025 CHMP meeting
8 December 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 08 Dec 2025
House passes bill that reauthorises the FDA’s paediatric priority voucher pathway
2 December 2025 - The US House of Representatives has passed a new piece of legislation that reauthorises the US ...
Posted by Michael Wonder on 08 Dec 2025
Incyte’s first in class mutCALR targeted monoclonal antibody, INCA033989, granted breakthrough therapy designation by US FDA
7 December 2025 - Incyte today announced that the US FDA has granted breakthrough therapy designation to INCA033989, a first ...
Posted by Michael Wonder on 07 Dec 2025
FDA approves Omisirge as first approved cell therapy to treat severe aplastic anaemia
5 December 2025 - Ayrmid announces that it has received US FDA approval for Omisirge (Omidubicel-onlv) for the treatment of ...
Posted by Michael Wonder on 06 Dec 2025
New resource: understanding Canada’s drug approval and reimbursement pathway
3 December 2025 - Understanding how new oncology and non-oncology drugs move through Canada’s regulatory and drug access pathways can ...