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 01 Sep 2021
NICE approves ground-breaking cholesterol lowering drug inclisiran
1 September 2021 - NICE has today issued draft final guidance recommending the novel anti-cholesterol drug inclisiran (Leqvio and made by ...
Posted by Michael Wonder on 01 Sep 2021
Amylyx Pharmaceuticals announces Health Canada accepts for review the new drug submission for AMX0035 for the treatment of ALS
31 August 2021 - Amylyx Pharmaceuticals today announced that Health Canada has accepted for review the new drug submission for AMX0035 ...
Posted by Michael Wonder on 01 Sep 2021
MicroTransponder receives FDA approval for breakthrough device benefiting stroke survivors
31 August 2021 - MicroTransponder today announced US FDA premarket approval of the Vivistim Paired VNS System, which significantly improves the ...
Posted by Michael Wonder on 01 Sep 2021
Jazz Pharmaceuticals announces Health Canada approval of Sunosi (solriamfetol) for excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea
31 August 2021 - Jazz Pharmaceuticals today announced the Health Canada approval and availability of Sunosi (solriamfetol) for the treatment ...
Posted by Michael Wonder on 01 Sep 2021
World first agreement between Novartis and the NHS enables broad and rapid access to first-in-class cholesterol-lowering medicine Leqvio (inclisiran)
1 September 2021 - Agreement follows positive NICE recommendation and commits to deliver Leqvio (inclisiran) access via a population health management ...
Posted by Michael Wonder on 31 Aug 2021
Price relief as epilepsy drug PBS listed
1 September 2021 - Australian epilepsy sufferers will now be reimbursed for a drug that reduces uncontrolled seizures, as a ...
Posted by Michael Wonder on 31 Aug 2021
Schedule of Pharmaceutical Benefits - 1 September 2021 update
1 September 2021 - The September 2021 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 31 Aug 2021
Real world outcomes associated with new cancer medicines approved by the FDA and EMA: a retrospective cohort study
August 2021 - Real world data studies are increasingly used to support regulatory approvals, reimbursement decisions, and changes in clinical practice ...
Posted by Michael Wonder on 31 Aug 2021
New Zealand Pharmaceutical Schedule - 1 September 2021 update
1 September 2021 - The September 2021 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 31 Aug 2021
Teva and MedinCell announce FDA acceptance of new drug application for TV-46000/mdc-IRM as a treatment for patients with schizophrenia
31 August 2021 - File acceptance marks important milestone for Teva’s commitment to treatments for mental disorders ...
Posted by Michael Wonder on 31 Aug 2021
FDA approves updated indication for Merck’s Keytruda (pembrolizumab) for treatment of certain patients with urothelial carcinoma (bladder cancer)
31 August 2021 - Keytruda approved for treatment of patients with locally advanced or metastatic urothelial carcinoma who are Not ...
Posted by Michael Wonder on 31 Aug 2021
ANI Pharmaceuticals announces FDA acceptance of purified Cortrophin gel supplemental new drug application for multiple indications including multiple sclerosis, rheumatoid arthritis and nephrotic syndrome
31 August 2021 - Prescription Drug User Fee Act target action date is 29 October 2021. ...
Posted by Michael Wonder on 31 Aug 2021
Ligand’s Partner Gloria Biosciences receives approval in China for zimberelimab for the treatment of recurrent or refractory classical Hodgkin’s lymphoma
31 August 2021 - First regulatory approval of an OmniAb derived antibody. ...
Posted by Michael Wonder on 30 Aug 2021
Zimmer Biomet and Canary Medical announce FDA de novo classification grant and authorisation to market the world's first and only smart knee implant
30 August 2021 - Post-operative gait metrics to provide real world, objective patient data. ...
Posted by Michael Wonder on 30 Aug 2021
UCB announces Briviact (brivaracetam) now FDA approved to treat partial-onset seizures in paediatric patients one month of age and older
30 August 2021 - Tablets, oral solution and intravenous dosage forms of Briviact (brivaracetam) now FDA approved as both monotherapy or ...