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 27 Jul 2022
GSK announces US FDA approval of Benlysta (belimumab) for paediatric patients with active lupus nephritis
27 July 2022 - Benlysta is now the first and only biologic approved for adults and children who have lupus ...
Posted by Michael Wonder on 27 Jul 2022
AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) in Crohn's disease
27 July 2022 - Submissions are supported by three Phase 3 clinical trials demonstrating upadacitinib achieved the co-primary endpoints of clinical ...
Posted by Michael Wonder on 27 Jul 2022
Lexicon announces FDA acceptance of new drug application for sotagliflozin to treat heart failure
27 July 2022 - NDA supported by SOLOIST-WHF and SCORED Global Phase 3 Program evaluating sotagliflozin in almost 12,000 people. ...
Posted by Michael Wonder on 27 Jul 2022
MS Health push for nurses to hand out abortion pills
27 July 2022 - Nurses and midwives would prescribe medical abortion pills under a push by the company that imports ...
Posted by Michael Wonder on 27 Jul 2022
MSAC publishes agenda for November 2022 meeting
27 July 2022 - 12 agenda items for consideration at the 24-25 November 2022 meeting. ...
Posted by Michael Wonder on 27 Jul 2022
FDA explains the ins and outs of real-time oncology review program in new guidance
26 July 2022 - Cancer drugs under development that show substantial promise over existing therapies and have simple study designs, as ...
Posted by Michael Wonder on 27 Jul 2022
Agenda for the November 2022 PBAC meeting
27 July 2022 - The agenda for the November 2022 PBAC meeting is now available. ...
Posted by Michael Wonder on 27 Jul 2022
Duvelisib for patients with chronic lymphocytic leukaemia
27 July 2022 - NICE has published a final technology appraisal for duvelisib for the treatment of patients with relapsed ...
Posted by Michael Wonder on 27 Jul 2022
EMA response to the monkeypox public health emergency
27 July 2022 - The EMA has initiated a series of actions to respond to the ongoing monkeypox outbreak, which ...
Posted by Michael Wonder on 26 Jul 2022
‘No magic bullet’: For drug makers and the FDA, clinical trials on ultra rare diseases pose thorny challenges
26 July 2022 - Walker Burger is beside himself with worry. ...
Posted by Michael Wonder on 26 Jul 2022
Henlius Hanquyou received TGA approval in Australia
26 July 2022 - Shanghai Henlius Biotech announced that the company's business partner Cipla has received the relevant registration certificates from ...
Posted by Michael Wonder on 26 Jul 2022
Lowest drug plan premium does not always mean lowest cost for you
26 July 2022 - Before Medicare, you probably had coverage through an employer group health plan. ...
Posted by Michael Wonder on 26 Jul 2022
45 medicines affected by supply issues as COVID causes 'unprecedented challenge'
27 July 2022 - In the past month, New Zealand has been hit by medicine supply issues affecting large swathes ...
Posted by Michael Wonder on 26 Jul 2022
Novavax announces expanded approval of Nuvaxovid COVID-19 vaccine for adolescents aged 12 through 17 in Japan
26 July 2022 - Nuvaxovid is the first protein-based COVID-19 vaccine approved for use in adolescents in Japan. ...
Posted by Michael Wonder on 26 Jul 2022
Ionis announces that FDA accepts new drug application and grants priority review of tofersen for a rare, genetic form of ALS
26 July 2022 - 12 month data included in the filing show that earlier initiation of tofersen slowed decline across measures ...