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 14 Jan 2021
Novartis ligelizumab (QGE031) receives FDA breakthrough therapy designation for patients with chronic spontaneous urticaria
14 January 2021 - Ligelizumab is the first treatment to receive FDA Breakthrough Therapy designation in chronic spontaneous urticaria in patients ...
Posted by Michael Wonder on 14 Jan 2021
ViiV Healthcare receives EU marketing authorisation for the first-ever dispersible-tablet formulation of dolutegravir, Tivicay, a treatment for children living with HIV in Europe
13 January 2021 - Dolutegravir is the first integrase inhibitor available as a dispersible tablet for children weighing at least 3kg ...
Posted by Michael Wonder on 14 Jan 2021
FDA releases artificial intelligence/machine learning action plan
12 January 2021 - Today, the U.S. FDA released the agency’s first artificial intelligence/machine learning-based software as a Medical Device Action ...
Posted by Michael Wonder on 14 Jan 2021
Workshop on evaluating RWE from observational studies in regulatory decision-making
12 January 2021 - The FDA and the Duke-Margolis Center for Health Policy will hold a virtual workshop focused on ...
Posted by Michael Wonder on 14 Jan 2021
Health Canada approves Imbruvica (ibrutinib) plus rituximab for the treatment of patients with chronic lymphocytic leukaemia
13 January 2021 - Patients aged 70 or younger with previously untreated CLL lived longer without disease progression compared to patients ...
Posted by Michael Wonder on 14 Jan 2021
CMS unleashes innovation to ensure our nation’s seniors have access to the latest advancements
12 November 2021 - Today, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that propels innovative technology ...
Posted by Michael Wonder on 14 Jan 2021
Amneal launches generic abiraterone acetate 500 mg tablets following ANDA approval by FDA
8 January 2021 - Amneal Pharmaceuticals announced that it has received approval of an additional strength of 500 mg to its ...
Posted by Michael Wonder on 13 Jan 2021
Insights from the outcomes from the November 2020 PBAC meeting
14 January 2021 - What distinguishes an 'outcome' from an 'other matter?" ...
Posted by Michael Wonder on 13 Jan 2021
CADTH publishes initial recommendation for nivolumab for NSCLC
9 January 2021 - The pERC has conditionally recommended the reimbursement of nivolumab when used in combination with ipilimumab and ...
Posted by Michael Wonder on 13 Jan 2021
CADTH publishes initial pCODR recommendation for entrectinib
9 January 2021 - pERC has conditionally recommended the reimbursement of entrectinib for the first-line treatment of patients with ROS1 positive ...
Posted by Michael Wonder on 13 Jan 2021
Push for Australia to develop a world-leading coronavirus vaccine
13 January 2021 - Australia could take the lead in a worldwide quest to find a long-term solution to COVID-19, ...
Posted by Michael Wonder on 13 Jan 2021
Cognito Therapeutics receives FDA breakthrough device designation for next-generation digital therapeutic in Alzheimer’s disease
12 January 2021 - Breakthrough designation is based on positive outcomes from clinical studies, and will advance the industry’s first next-generation ...
Posted by Michael Wonder on 13 Jan 2021
Leading BioSciences announces FDA fast track designation granted to LB1148 for the treatment of post-operative gastro-intestinal dysfunction associated with paediatric cardiovascular surgery
13 January 2021 - LBS expects to initiate a pivotal trial in 2021. ...
Posted by Michael Wonder on 13 Jan 2021
Innovent announces NMPA acceptance of a supplemental new drug application for Tyvyt (sintilimab injection) in combination with Byvasda (bevacizumab injection) as first-line therapy in hepatocellular carcinoma
12 January 2021 - Innovent Biologics today announced that the National Medical Products Administration of China has accepted the supplemental ...
Posted by Michael Wonder on 13 Jan 2021
Government races to secure more vaccines but stares down AstraZeneca critics
13 January 2021 - The Morrison government is seeking new deals to vaccinate millions of Australians by the middle of ...