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 May 2021
Avenda Health granted FDA breakthrough device designation for technology to treat prostate cancer
11 May 2021 - Avenda Health advances male “lumpectomy” for prostate cancer with new in office, AI based focal therapy system. ...
Posted by Michael Wonder on 11 May 2021
MHRA approves label extension for Vertex’s Kaftrio combo
11 May 2021 - The UK MHRA has approved a label extension for Vertex’s cystic fibrosis treatment Kaftrio in combination ...
Posted by Michael Wonder on 11 May 2021
Additional measures to allow experts to focus on COVID-19 activities
11 May 2021 - EMA is implementing additional temporary measures to further streamline activities in the European medicines regulatory network ...
Posted by Michael Wonder on 11 May 2021
BMS withdraws application for Opdivo/Yervoy combination
11 May 2021 - Details revealed in new AusPAR. ...
Posted by Michael Wonder on 11 May 2021
US, EU regulators discuss tailoring biosimilar approvals
11 May 2021 - A tailored approach to biosimilar approvals is conceived as the next big leap for regulatory advancement in ...
Posted by Michael Wonder on 10 May 2021
NSW residents aged in 40-49 age group could get COVID-19 vaccine in coming weeks
10 May 2021 - NSW residents aged 40 to 49 are now eligible to register for a Pfizer vaccination and could ...
Posted by Michael Wonder on 10 May 2021
ISPOR announces 2021-2022 Board of Directors
10 May 2021 - Isao Kamae moves into role as President. ...
Posted by Michael Wonder on 10 May 2021
FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents in another important action in fight against pandemic
10 May 2021 - Today, the U.S. FDA expanded the emergency use authorisation for the Pfizer-BioNTech COVID-19 vaccine for the prevention ...
Posted by Michael Wonder on 10 May 2021
A refreshed evidence standards framework for digital health technologies and an increased focus on digital health for NICE
10 May 2021 - Two exciting developments which will accelerate NICE’s efforts to deliver innovation to the health and care system ...
Posted by Michael Wonder on 10 May 2021
Medicines for colorectal, skin and ovarian cancers approved for NHS Scotland use
10 May 2021 - The Scottish Medicines Consortium accepted a treatment of colorectal cancer in patients with a gene mutation called ...
Posted by Michael Wonder on 10 May 2021
Budget 2021: Alison Day meets with Greg Hunt to help other cancer sufferers
10 May 2021 - Mum of two Alison Day - who has a terminal breast cancer diagnosis - has secured more ...
Posted by Michael Wonder on 10 May 2021
SMC - May 2021 decisions
10 May 2021 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has announced today that ...
Posted by Michael Wonder on 10 May 2021
Dutch advisory group says Zolgensma shouldn’t be covered unless Novartis halves price
10 May 2021 - In a challenge to Novartis, a Dutch advisory body has recommended that the government not cover ...
Posted by Michael Wonder on 10 May 2021
Smart Immune announces FDA orphan drug status, IND acceptance and fast track designation to commence Phase 1/2 clinical trial of proprietary allogeneic T cell progenitor product SMART 101 (ProTcell) for AML and ALL
10 May 2021 - Phase 1/2 trial to begin by fall 2021 at a top US cancer centre. ...
Posted by Michael Wonder on 10 May 2021
Amgen announces tezepelumab biologics license application submitted to U.S. FDA
10 May 2021 - Potential first in class medicine blocking TSLP, an epithelial sytokine. ...