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 Jun 2024
Carisma Therapeutics granted FDA fast track designation for CT-0525 for the treatment of HER2 overexpressing solid tumours
25 June 2024 - Initial Phase 1 data expected by year end 2024. ...
Posted by Michael Wonder on 27 Jun 2024
HHS announces cost savings for 64 prescription drugs thanks to the Medicare Rebate Program established by the Biden-Harris Administration’s Lower Cost Prescription Drug Law
26 June 2024 - Under President Biden’s Inflation Reduction Act, some people with Medicare will pay less for some Part ...
Posted by Michael Wonder on 27 Jun 2024
Bavarian Nordic submits marketing authorisation application for its chikungunya vaccine candidate to EMA
26 June 2024 - Regulatory review of the single-dose CHIKV VLP vaccine candidate for immunization to prevent disease caused by ...
Posted by Michael Wonder on 27 Jun 2024
Ionis announces olezarsen FCS new drug application accepted for priority review
26 June 2024 - Olezarsen PDUFA date set for 19 December 2024 for treatment of familial chylomicronemia syndrome. ...
Posted by Michael Wonder on 27 Jun 2024
Patritumab deruxtecan BLA submission receives complete response letter from FDA due to inspection findings at third-party manufacturer
27 June 2024 - The letter did not identify any issues with the efficacy or safety data submitted in the ...
Posted by Michael Wonder on 26 Jun 2024
Tofidence (tocilizumab), a biosimilar referencing RoActemra, approved in the European Union
24 June 2024 - Tofidence complements existing portfolio of immunology biosimilars commercialised by Biogen ...
Posted by Michael Wonder on 26 Jun 2024
Harmony Biosciences receives US FDA approval for Wakix (pitolisant) in paediatric patients with narcolepsy
24 June 2024 - FDA granted priority review of the sNDA in February 2024. ...
Posted by Michael Wonder on 26 Jun 2024
Tagrisso with the addition of chemotherapy approved in China as first-line treatment for patients with EGFR-mutated advanced lung cancer
26 June 2024 - Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy reduced the risk of disease progression ...
Posted by Michael Wonder on 26 Jun 2024
Otsuka and Lundbeck announce FDA acceptance of sNDA filing for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder
25 June 2024 - The FDA target date (PDUFA date) for completion of the review is 8 February 2025. ...
Posted by Michael Wonder on 26 Jun 2024
ExCellThera announces EMA’s acceptance under accelerated assessment of market authorisation application for UM171 cell therapy for patients with haematological malignancies who lack a readily available suitable donor
25 June 2024 - ExCellThera announced today that the market authorisation application for UM171 cell therapy (INN-dorocubicel) has been accepted under ...
Posted by Michael Wonder on 26 Jun 2024
UCB’s epilepsy drug Briviant (brivaracetam) approved in Japan for treatment of focal onset seizures
26 June 2024 - Approval is supported by positive results from a Phase 3 clinical study which evaluated the efficacy ...
Posted by Michael Wonder on 26 Jun 2024
Health Canada authorizes Lilly's Ebglyss (lebrikizumab) for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older
25 June 2024 - Patients treated with Ebglyss experienced significant skin clearance and itch relief as early as 4 weeks. ...
Posted by Michael Wonder on 25 Jun 2024
Roche’s Ocrevus subcutaneous administration approved by European Commission, as first and only twice-a-year injection for relapsing and primary progressive multiple sclerosis
25 June 2024 - Roche is working closely with national health systems in Europe to ensure people with multiple sclerosis ...
Posted by Michael Wonder on 25 Jun 2024
PHARMAC ‘on notice’ as cancer patient advocates welcome ‘incredible’ medicines spend
25 June 2024 - Advocates of cancer patients say PHARMAC is now “on notice” to deliver the 26 Government-funded cancer ...
Posted by Michael Wonder on 25 Jun 2024
AbbVie provides US regulatory update on ABBV-951 (foscarbidopa/foslevodopa)
25 June 2024 - AbbVie continues to work with the FDA to bring ABBV-951 to patients in the US as ...