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 09 Mar 2023
Updates from the Health Technology Assessment Policy and Methods Review Reference Committee (March 2023)
9 March 2023 - The Health Technology Assessment Policy and Methods Review Reference Committee met on 13 February 2023. ...
Posted by Michael Wonder on 08 Mar 2023
Jazz Pharmaceuticals secures eight additional provincial reimbursements for Vyxeos for treatment of adults with newly diagnosed therapy-related acute myeloid leukaemia or acute myeloid leukaemia with myelodysplasia-related changes
8 March 2023 - Jazz Pharmaceuticals announced today that Vyxeos (daunorubicin and cytarabine liposome for injection) is now included on eight ...
Posted by Michael Wonder on 08 Mar 2023
Biden calls for tax on the wealthy to extend Medicare funding
8 March 2023 - President Joe Biden this week called for higher taxes on wealthy Americans to extend Medicare funding as ...
Posted by Michael Wonder on 08 Mar 2023
Preterm birth drug withdrawn after 12 years
7 March 2023 - The FDA seemed poised to rescind approval of Makena, after studies over time indicated the treatment did ...
Posted by Michael Wonder on 08 Mar 2023
Amphastar Pharmaceuticals receives FDA approval for naloxone hydrochloride nasal spray 4 mg
8 March 2023 - Amphastar Pharmaceuticals announced that the US FDA has granted approval of its new drug application for ...
Posted by Michael Wonder on 08 Mar 2023
US FDA accepts supplemental new drug application for Jardiance for children 10 years and older with type 2 diabetes
8 March 2023 - The application is based on phase III results from the DINAMO trial showing Jardiance (empagliflozin) tablets significantly ...
Posted by Michael Wonder on 08 Mar 2023
NICE recommended weight loss drug to be made available in specialist NHS services
8 March 2023 - Thousands of people will soon be able to be prescribed a drug to help them lose weight ...
Posted by Michael Wonder on 08 Mar 2023
FDA accepts Mesoblast’s resubmission of the biologic license application for remestemcel-L in children with steroid-refractory acute graft versus host disease as a complete response
7 March 2023 - If approved, remestemcel-L will be the first allogeneic “off the shelf” cellular medicine in the US and ...
Posted by Michael Wonder on 08 Mar 2023
FDA accepts Novan’s NDA for berdazimer 10.3% topical gel for the treatment of molluscum contagiosum
7 March 2023 - FDA completes filing review of application with no filing issues identified. ...
Posted by Michael Wonder on 08 Mar 2023
The unique device identifier: a unique opportunity
7 March 2023 - A unique device identifier is an individualised alphanumeric signature associated with a single medical device. Since 2013, ...
Posted by Michael Wonder on 08 Mar 2023
Genethon given PRIME status by EMA for gene therapy to treat Crigler-Najjar syndrome, a rare liver disease
7 March 2023 - Genethon today announced that the EMA has granted PRIME (Priority Medicines) status to the gene therapy, ...
Posted by Michael Wonder on 08 Mar 2023
In Amsterdam, EU drugs regulator doesn’t want brothel moving in next door
7 March 2023 - Sex and drugs don’t mix, argues the EMA. ...
Posted by Michael Wonder on 08 Mar 2023
FDA accepts BioMarin's supplemental new drug application to expand use of Voxzogo (vosoritide) for injection to treat children with achondroplasia under the age of 5
7 March 2023 - FDA set PDUFA target action date of 21 October 2023. ...
Posted by Michael Wonder on 07 Mar 2023
FDA grants Lenire tinnitus treatment device de novo approval
7 March 2023 - FDA approval based on results of 112 patient pivotal TENT-A3 clinical trial supported by confirmatory real world ...
Posted by Michael Wonder on 07 Mar 2023
Shorla Oncology announces US FDA approval of nelarabine injection for the treatment of T-cell leukaemia
7 March 2023 - Nelarabine injection ensures access to a lifesaving treatment that historically has been in shortage. ...