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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 28 Feb 2023
Axicabtagene ciloleucel for the treatment of adults with diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma after two or more systemic therapies
28 February 2023 - This appraisal reviews the additional evidence collected as part of the Cancer Drugs Fund managed access ...
Posted by Michael Wonder on 28 Feb 2023
Supplies secured of latest Moderna COVID-19 vaccine as recommended by Halton Review
28 February 2023 - The Australian Government has secured an additional 3 million doses of the latest Moderna Omicron-specific COVID-19 vaccine ...
Posted by Michael Wonder on 27 Feb 2023
Doctor with Stage 4 cancer is refused access to lifesaving treatment on the NHS
27 February 2023 - Dr Asha Umrawsingh, 50, was first diagnosed with breast cancer in 2010. ...
Posted by Michael Wonder on 27 Feb 2023
Areteia Therapeutics granted ILAP designation from UK MHRA for oral dexpramipexole for eosinophilic asthma
23 February 2023 - Areteia Therapeutics today announced that the UK’s MHRA has granted an Innovation Passport under the Innovative Licensing ...
Posted by Michael Wonder on 27 Feb 2023
SpringWorks Therapeutics announces FDA acceptance and priority review of new drug application for nirogacestat for the treatment of adults with desmoid tumours
27 February 2023 - PDUFA action date set for 27 August 2023. ...
Posted by Michael Wonder on 27 Feb 2023
Glaukos submits new drug application to US FDA for iDose TR
27 February 2023 - Glaukos today announced the submission of its new drug application to the US FDA for iDose® TR. ...
Posted by Michael Wonder on 27 Feb 2023
For Cytokinetics, an FDA rejection of its heart drug would help, not hinder
27 February 2023 - Cytokinetics was founded 26 years ago but has not yet developed a drug successfully to approval. ...
Posted by Michael Wonder on 27 Feb 2023
EMA pilots scientific advice for certain high risk medical devices
27 February 2023 - The EMA has launched a pilot to give scientific advice on the intended clinical development strategy ...
Posted by Michael Wonder on 27 Feb 2023
Pfizer and BioNTech submit supplemental biologics license application for US FDA approval of Omicron BA.4/BA.5 adapted bivalent COVID-19 vaccine for ages 12 years and older as primary series or booster
24 February 2023 - Pfizer and BioNTech today announced they have submitted a supplemental biologics license application to the US ...
Posted by Michael Wonder on 27 Feb 2023
Incyte announces positive CHMP opinion for ruxolitinib cream (Opzelura) for the treatment of non-segmental vitiligo in adults and adolescents
24 February 2023 - The positive CHMP opinion is based on Phase 3 data showing treatment with ruxolitinib cream resulted in ...
Posted by Michael Wonder on 27 Feb 2023
Celltrion has come forward to explain reasons for the delayed approval of its Humira biosimilar, Yuflyma (CT-P17), in the US, saying there were some problems, but they have been solved now
24 February 2023 - Celltrion has come forward to explain reasons for the delayed approval of its Humira biosimilar, Yuflyma ...
Posted by Michael Wonder on 27 Feb 2023
AbbVie receives positive CHMP opinion for upadacitinib (Rinvoq) for the treatment of adults with moderate to severe Crohn's disease
27 February 2023 - The positive CHMP opinion for upadacitinib is based on results from two induction studies and one maintenance ...
Posted by Michael Wonder on 26 Feb 2023
Servier receives a positive CHMP opinion for Tibsovo in IDH1 mutated acute myeloid leukaemia and cholangiocarcinoma patients
24 February 2023 - The positive CHMP opinion is based on clinical data from the AGILE (in AML) and ClarIDHy (in ...
Posted by Michael Wonder on 26 Feb 2023
Minister for Health publishes review of governance arrangements to support HSE drug reimbursement process
24 February 2023 - The Minister for Health today published a Report prepared by Mazars which examines the governance arrangements ...
Posted by Michael Wonder on 25 Feb 2023
Health technology assessment 2025 and beyond: lifecycle approaches to promote engagement and efficiency in health technology assessment
23 February 2023 - Lifecycle considerations have always been part of health technology assessment. However, the concept of taking a fuller, ...