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 12 Jan 2021
EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca
12 January 2020 - EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by AstraZeneca ...
Posted by Michael Wonder on 12 Jan 2021
Health Canada approves Bavencio for the maintenance treatment of patients with advanced bladder cancer
11 January 2021 - Bavencio is the first and only maintenance therapy for unresectable locally advanced or metastatic urothelial carcinoma ...
Posted by Michael Wonder on 12 Jan 2021
Acrux receives FDA approval for its generic testosterone topical solution
12 January 2021 - Acrux is pleased to announce that the US FDA has approved its generic product based on ...
Posted by Michael Wonder on 12 Jan 2021
From 1 February 2021 pre-COVID-19 Special Authority criteria will be reinstated
12 January 2020 - The temporary changes will remain in place for any Special Authority applications for the relevant medicines made ...
Posted by Michael Wonder on 12 Jan 2021
ObsEva provides update on Yselty (linzagolix) clinical development program
11 January 2021 - European Medicines Agency validates Yselty marketing authorisation application for uterine fibroids; US NDA Planned for 1H 2021. ...
Posted by Michael Wonder on 12 Jan 2021
Aerie Pharmaceuticals receives European Commission approval for Roclanda (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%
11 January 2021 - Aerie Pharmaceuticals today announced the European Commission has granted a marketing authorisation for Roclanda (netarsudil and latanoprost ...
Posted by Michael Wonder on 12 Jan 2021
Decision to widen access to valganciclovir for transplant patients
12 January 2021 - PHARMAC is pleased to announce a decision to widen access to valganciclovir for use after lung ...
Posted by Michael Wonder on 11 Jan 2021
Exicure granted two fast track designations for cavrotolimod (AST-008) from the U.S. Food and Drug Administration
11 January 2021 - Exicure today announced that the U.S. FDA has granted fast track designations for its clinical product ...
Posted by Michael Wonder on 11 Jan 2021
Insights from the January 2021 issue of the Schedule of Pharmaceutical Benefits
12 January 2021 - The January 2021 issue of the Schedule of Pharmaceutical Benefits tells very different tales for two innovative ...
Posted by Michael Wonder on 11 Jan 2021
Most Australians will get the AstraZeneca coronavirus vaccine, but priority groups will receive the Pfizer drug. What's the difference?
12 January 2021 - As Australians navigate lockdowns, border closures, hotel quarantine and COVID-19 testing queues, the wait for the ...
Posted by Michael Wonder on 11 Jan 2021
Myriad Genetics receives first reimbursement decision for myChoice diagnostic system in Japan, enabling women with ovarian cancer to benefit from treatment with Zejula
8 January 2021 - Myriad Genetics announced today that it received its first reimbursement decision for the Myriad myChoice Diagnostic System, ...
Posted by Michael Wonder on 11 Jan 2021
Democrats have their best shot yet at letting Medicare negotiate drug prices — but it’s still not a done deal
11 January 2021 - Democrats have their best shot in more than a decade to deliver on one of the ...
Posted by Michael Wonder on 11 Jan 2021
Organogenesis ReNu receives FDA regenerative medicine advanced therapy designation for osteoarthritis of the knee
11 January 2021 - FDA determines ReNu preliminary clinical evidence indicates potential to address unmet medical needs for the management of ...
Posted by Michael Wonder on 11 Jan 2021
SMC to support innovative new medicines pathway
29 December 2020 - Experts from the Scottish Medicines Consortium are to support a new licensing and access pathway which ...
Posted by Michael Wonder on 11 Jan 2021
US FDA accepts supplemental new drug application for Jardiance (empagliflozin) for adults with heart failure with reduced ejection fraction
11 January 2021 - The U.S. FDA has accepted a supplemental new drug application for Jardiance (empagliflozin) which is being ...