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 12 Dec 2025
Update from the PBAC (December 2025)
12 December 2025 - The PBAC update following the November 2025 PBAC meeting is now available. ...
Posted by Michael Wonder on 12 Dec 2025
FDA approves Uplinza for adults with generalised myasthenia gravis
11 December 2025 - Amgen today announced that the US FDA has approved Uplinza (inebilizumab-cdon) for the treatment of generalised myasthenia ...
Posted by Michael Wonder on 12 Dec 2025
Landmark UK-US pharmaceuticals deal to safeguard medicines access and drive vital investment for UK patients and businesses
1 December 2025 - Tens of thousands of NHS patients will benefit from a landmark trade deal between the UK and the ...
Posted by Michael Wonder on 12 Dec 2025
PTC Therapeutics announces Health Canada approval of Sephience (sepiapterin) for the treatment of children and adults living with phenylketonuria
10 December 2025 - PTC Therapeutics Canada announced that Health Canada has approved Sephience (sepiapterin) for the treatment of children and ...
Posted by Michael Wonder on 11 Dec 2025
ICER publishes evidence report on medication for smoking cessation
11 December 2025 - Cytisinicline is effective for smoking cessation; a 12 week course of cytisinicline would be cost effective ...
Posted by Michael Wonder on 11 Dec 2025
Kymera Therapeutics announces US FDA fast track designation for KT-621, a first in class, oral STAT6 degrader for the treatment of atopic dermatitis
11 December 2025 - Fast track designation supported by positive results from the KT-621 BroADen Phase 1b atopic dermatitis patient trial. ...
Posted by Michael Wonder on 11 Dec 2025
Tris Pharma announces FDA acceptance of NDA for once nightly, low sodium oxybate product for narcolepsy and idiopathic hypersomnia
9 December 2025 - Tris Pharma today announced that the US FDA has accepted the company’s new drug application for TRN-257 ...
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 ...