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 17 Mar 2026
PBAC advice on equitable access to GLP-1 obesity treatments
17 March 2026 - On 6 March 2025, Minister Butler wrote to the PBAC to request the Committee’s advice on ...
Posted by Michael Wonder on 17 Mar 2026
Sun Pharma announces US FDA acceptance of supplemental biologics license application for Ilumya (tildrakizumab-asmn) for the treatment of adults with active psoriatic arthritis
16 March 2026 - Sun Pharmaceutical Industries announced that the US FDA has accepted for review the supplemental biologics license ...
Posted by Michael Wonder on 17 Mar 2026
Argo Biopharma receives FDA fast track designation for BW-20805, an investigational siRNA therapy for the treatment of HAE
16 March 2026 - Global Phase 2 open-label study in adult hereditary angioedema patients on-going, company on track for primary completion ...
Posted by Michael Wonder on 16 Mar 2026
Cogent Biosciences announces FDA acceptance of new drug application for bezuclastinib in patients with non-advanced systemic mastocytosis
16 March 2026 - NDA based on positive clinical results from the SUMMIT pivotal trial in which bezuclastinib demonstrated clear clinical ...
Posted by Michael Wonder on 16 Mar 2026
Imfinzi approved in the EU as first and only peri-operative immunotherapy for patients with early gastric and gastro-oesophageal cancers
16 March 2026 - Approval based on MATTERHORN Phase 3 trial demonstrating statistically significant and clinically meaningful improvements in event-free ...
Posted by Michael Wonder on 16 Mar 2026
EMA proposes new paper on proof of concept studies for paediatric oncology drugs
13 March 2026 - The EMA has released a concept paper proposing a future reflection paper on the development of ...
Posted by Michael Wonder on 16 Mar 2026
Telix resubmits NDA to US FDA for TLX101-Px (Pixclara) brain cancer imaging candidate
16 March 2026 - Telix Pharmaceuticals today announces the resubmission of a new drug application to the US FDA for ...
Posted by Michael Wonder on 15 Mar 2026
The end of cancer: how cell therapy breakthroughs have us on the edge of a cure
15 March 2026 - How rapid immunotherapy advancements could relegate killer cancers to the status of a ‘chronic disease’. ...
Posted by Michael Wonder on 13 Mar 2026
Novartis Cosentyx receives FDA approval for paediatric patients aged 12+ with moderate to severe hidradenitis suppurativa
13 March 2026 - Novartis announced today that Cosentyx (secukinumab) received US FDA approval for treating paediatric patients 12 years ...
Posted by Michael Wonder on 13 Mar 2026
GSK’s RSV vaccine, Arexvy, approved in US for expanded age indication in adults aged 18–49 years at increased risk
13 March 2026 - GSK today announced that the US FDA has expanded the approved age indication of Arexvy (respiratory syncytial ...
Posted by Michael Wonder on 13 Mar 2026
MHRA approves deuruxolitinib (Leqselvi) to treat severe alopecia areata in adults
12 March 2026 - The MHRA has approved deuruxolitinib (Leqselvi) to treat severe alopecia areata in adults. ...
Posted by Michael Wonder on 12 Mar 2026
ICER releases draft evidence report on treatment for narcolepsy
12 March 2026 - Public comment period now open until 7 April 2026; requests to make oral comment during public ...
Posted by Michael Wonder on 12 Mar 2026
500,000 eligible to benefit from new non-hormonal treatment for hot flushes caused by menopause
11 March 2026 - A new treatment option for menopausal hot flushes and night sweats can be used in the NHS ...
Posted by Michael Wonder on 12 Mar 2026
ARTHEx Biotech granted FDA fast track designation for ATX-01 for the treatment of myotonic dystrophy type 1
11 March 2026 - ARTHEx Biotech today announced that the US FDA has granted fast track designation to ATX-01 for the ...
Posted by Michael Wonder on 12 Mar 2026
Health ministry cautious on timing of generic drug price cuts, reaffirms ‘no-exception’ principle
11 March 2026 - Amid mounting opposition from the pharmaceutical industry over the government's proposed “drug pricing system improvement plan,” ...