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 Oct 2025
Silver Creek Pharmaceuticals receives FDA fast track designation for Scp776 in acute ischaemic stroke
17 October 2025 - Silver Creek Pharmaceuticals today announced that the US FDA has granted fast track designation to scp776, its ...
Posted by Michael Wonder on 17 Oct 2025
Health Economics Methods Advisory Group releases draft report: asssessing treatment benefits in health technology assessment decision-making
9 October 2025 - Public comment period now open until 30 October 2025. ...
Posted by Michael Wonder on 17 Oct 2025
Highlights from the 13-16 October 2025 CHMP meeting
17 October 2025 - The EMA’s CHMP has recommended two medicines for approval at its October 2025 meeting. ...
Posted by Michael Wonder on 17 Oct 2025
Tezspire approved in the US for chronic rhinosinusitis with nasal polyps
17 October 2025 - AstraZeneca and Amgen’s Tezspire (tezepelumab) has been approved in the US for the add-on maintenance treatment of ...
Posted by Michael Wonder on 17 Oct 2025
ICER to assess treatment for narcolepsy
17 October 2025 - Report will be subject of Midwest CEPAC meeting in May 2026; draft scoping document open to ...
Posted by Michael Wonder on 17 Oct 2025
Saphnelo subcutaneous self-administration recommended for approval in EU by CHMP for systemic lupus erythematosus
17 October 2025 - Recommendation based on TULIP-SC Phase III trial results showing first in class Saphnelo reduced disease activity ...
Posted by Michael Wonder on 17 Oct 2025
Libtayo (cemiplimab) recommended for EU approval by the CHMP for adjuvant treatment of cutaneous squamous cell carcinoma with a high risk of recurrence after surgery and radiation
17 October 2025 - Positive opinion based on results of Phase 3 C-POST trial that show Libtayo significantly reduced the ...
Posted by Michael Wonder on 17 Oct 2025
Novartis Scemblix receives positive CHMP opinion for the treatment of adults with newly diagnosed CML
17 October 2025 - If approved, Scemblix will be indicated for adults with chronic myeloid leukaemia (CML), both newly diagnosed and ...
Posted by Michael Wonder on 17 Oct 2025
Rare cancer lifeline comes with dual drug discounts
17 October 2025 - Two common immunotherapy drugs will now be subsidised for all advanced or metastatic cancers, providing a ...
Posted by Michael Wonder on 17 Oct 2025
Immunotherapy for patients with advanced cancers
17 October 2025 - More Australians living with advanced cancer could have access to immunotherapy treatment options, thanks to a ...
Posted by Michael Wonder on 17 Oct 2025
First HIV prevention injection for people unable to have daily PrEP recommended
17 October 2025 - A ground-breaking HIV-1 prevention injection has been recommended by NICE, marking a significant advance for a small ...
Posted by Michael Wonder on 17 Oct 2025
Same time decisions on licensing and value - what pharmaceutical companies need to know
10 October 2025 - Learn how NICE and MHRA are launching an aligned pathway to accelerate patient access to medicines and ...
Posted by Michael Wonder on 17 Oct 2025
Merck announces unprecedented agreement with US Government to expand access to IVF therapies
16 October 2025 - Merck announced today that EMD Serono, the healthcare business of Merck in the US and Canada, ...
Posted by Michael Wonder on 16 Oct 2025
NovelWise Pharmaceutical receives FDA fast track designation for NBM-BMX in metastatic uveal melanoma
14 October 2025 - NovelWise Pharmaceutical today announced that the US FDA has granted fast track designation for NBM-BMX, a ...
Posted by Michael Wonder on 16 Oct 2025
atai Life Sciences and Beckley Psytech announce US FDA breakthrough therapy designation granted to BPL-003, underscoring its potential in treatment-resistant depression
16 October 2025 - FDA designation follows previously announced Phase 2b topline data which showed rapid and durable anti-depressant outcomes following ...