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 06 Feb 2025
Acrivon Therapeutics announces FDA has granted breakthrough device designation for ACR-368 OncoSignature assay for endometrial cancer
5 February 2025 - The ACR-368-tailored OncoSignature assay is being used to predict patients most likely to respond to ACR-368 in ...
Posted by Michael Wonder on 06 Feb 2025
FDA approves treosulfan with fludarabine as a preparative regimen for alloHSCT in adult and paediatric patients with AML or MDS
21 January 2025 - Today, the FDA approved treosulfan (Grafapex, medac), an alkylating agent, with fludarabine as a preparative regimen ...
Posted by Michael Wonder on 06 Feb 2025
Supernus announces FDA approval of Onapgo (apomorphine hydrochloride) for Parkinson’s disease
4 February 2025 - Supernus Pharmaceuticals announced today that the US FDA approved Onapgo (apomorphine hydrochloride) injection, formerly known as SPN-830, ...
Posted by Michael Wonder on 06 Feb 2025
Serplulimab approved in the EU for first-line treatment of extensive-stage small cell lung cancer
5 February 2025 - Serplulimab is the world's first anti-PD-1 monoclonal antibody approved for first-line treatment of extensive stage small-cell lung ...
Posted by Michael Wonder on 06 Feb 2025
Bayer files for approval of finerenone in heart failure in the EU
3 February 2025 - Regulatory submission is based on positive data from the Phase 3 FINEARTS-HF study presented at ESC Congress ...
Posted by Michael Wonder on 05 Feb 2025
Adicet Bio receives FDA fast track designation for ADI-001 for the treatment of refractory systemic lupus erythematosus with extra-renal involvement
5 February 2025 - Adicet Bio today announced the US FDA has granted fast track designation to ADI-001 for the ...
Posted by Michael Wonder on 05 Feb 2025
Astellas submits new drug application for conditional approval of avacincaptad pegol for geographic atrophy in Japan
5 February 2025 - Ministry of Health, Labour and Welfare to evaluate avacincaptad pegol as potential first and only treatment for ...
Posted by Michael Wonder on 05 Feb 2025
Izchiq vaccine approved to protect adults against Chikungunya
4 February 2025 - The MHRA has today approved the vaccine chikungunya vaccine (live) (Ixchiq) to protect adults against chikungunya disease, ...
Posted by Michael Wonder on 05 Feb 2025
Update on regulatory review of lecanemab for early Alzheimer’s disease in the European Union (July 2024)
26 July 2024 - Eisai and Biogen announced today that the CHMP of the EMA has adopted a negative opinion on ...
Posted by Michael Wonder on 05 Feb 2025
Pembrolizumab for adjuvant treatment of patients with resected non-small-cell lung cancer (final guidance)
5 February 2025 - NICE has published final evidence-based recommendations on the use of pembrolizumab (Keytruda) for the adjuvant treatment ...
Posted by Michael Wonder on 05 Feb 2025
Elacestrant dihydrochloride for the treatment of patients with advanced, oestrogen receptor positive, HER2 negative breast cancer with an ESR1 mutation after endocrine treatment (final guidance)
5 February 2025 - Evidence-based recommendations on elacestrant (Korserdu) for treating oestrogen receptor-positive HER2-negative advanced breast cancer with an ESR1 mutation ...
Posted by Michael Wonder on 05 Feb 2025
Medexus and Ontario's Provincial Health Services successfully complete agreements for public reimbursement of Trecondyv (treosulfan for injection) in Ontario, Canada
4 February 2025 - Medexus recently completed listing agreements with Ontario's Ministry of Health (Ontario Public Drug Programs) and Ontario ...
Posted by Michael Wonder on 05 Feb 2025
Gilead submits marketing authorisation applications to EMA for twice yearly lenacapavir for HIV prevention
3 February 2025 - One application seeks European Commission authorisation; other application would help facilitate availability in low and lower middle ...
Posted by Michael Wonder on 05 Feb 2025
FDA approves Roche’s Susvimo as the first and only continuous delivery treatment for the leading cause of diabetes-related blindness
4 February 2025 - Approval marks the second indication for Susvimo in addition to neovascular or ‘wet’ age-related macular degeneration, ...
Posted by Michael Wonder on 04 Feb 2025
Comanche Biopharma awarded Innovation passport designation by the UK Innovative Licensing and Access Pathway Steering Group for CBP-4888, an investigational siRNA drug candidate for the treatment of sFlt1-mediated preterm pre-eclampsia
30 January 2025 - A novel investigational drug candidate, CBP-4888 leverages the precise targeting ability of siRNAs to downregulate sFlt1 ...