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RSS FeedPosted by Michael Wonder on 13 Aug 2024
Lenz Therapeutics announces submission of new drug application to US FDA for LNZ100 for the treatment of presbyopia
12 August 2024 - Lenz Therapeutics today announced that the Company has submitted a new drug application to US FDA for ...
Posted by Michael Wonder on 13 Aug 2024
Wave Life Sciences receives FDA rare paediatric disease designation for WVE-N531 for the treatment of Duchenne muscular dystrophy
12 August 2024 - Wave Life Sciences today announced that the US FDA has granted rare paediatric disease designation to WVE-N531 ...
Posted by Michael Wonder on 12 Aug 2024
FDA approves Yorvipath (palopegteriparatide) as the first and only treatment for hypoparathyroidism in adults
12 August 2024 - Ascendis Pharma today announced that the US FDA has approved Yorvipath (palopegteriparatide; developed as TransCon PTH) for ...
Posted by Michael Wonder on 12 Aug 2024
Actio Biosciences receives orphan drug and rare paediatric disease designations for the treatment of Charcot-Marie-Tooth disease 2C
8 August 2024 - Actio Biosciences today announced the US FDA has granted both orphan drug designation and rare paediatric disease ...
Posted by Michael Wonder on 12 Aug 2024
Sandoz receives FDA approval for Enzeevu (aflibercept-abzv), further strengthening US biosimilar position
12 August 2024 - Enzeevu (aflibercept-abzv) approved to treat neovascular age-related macular degeneration. ...
Posted by Michael Wonder on 11 Aug 2024
Satellos receives rare paediatric disease designation from the US FDA for SAT-3247 for the treatment of Duchenne muscular dystrophy
8 August 2024 - Satellos Bioscience announced today that the US FDA has granted rare paediatric disease designation to SAT-3247 ...
Posted by Michael Wonder on 10 Aug 2024
Amneal receives US FDA approval for IPX203 for treatment of Parkinson’s disease to be launched as Crexont (carbidopa and levodopa) extended release capsules
7 August 2024 - Crexont commercial launch planned in September 2024. ...
Posted by Michael Wonder on 09 Aug 2024
Lykos Therapeutics announces complete response letter for midomafetamine capsules for PTSD
9 August 2024 - US FDA requests additional Phase 3 study. ...
Posted by Michael Wonder on 09 Aug 2024
FDA approves first nasal spray for treatment of anaphylaxis
9 August 2024 - Today, the US FDA approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type ...
Posted by Michael Wonder on 09 Aug 2024
FDA approves first nalmefene hydrochloride auto-injector to reverse opioid overdose
7 August 2024 - Today, the US FDA approved Zurnai, the first nalmefene hydrochloride auto-injector for the emergency treatment of known ...
Posted by Michael Wonder on 09 Aug 2024
Citius Pharmaceuticals receives FDA approval for Lymphir (denileukin diftitox-cxdl) immunotherapy for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma
8 August 2024 - Lymphir is expected to launch within the next five months. ...
Posted by Michael Wonder on 08 Aug 2024
Takeda receives European Commission approval for Adzynma (recombinant ADAMTS13) as the first and only recombinant ADAMTS13 replacement therapy for congenital thrombotic thrombocytopenic purpura
7 August 2024 - Approval based on totality of evidence, including results from the first randomised, controlled, open-label, cross-over Phase ...
Posted by Michael Wonder on 08 Aug 2024
Neurogene announces RMAT designation for NGN-401 investigational gene therapy for Rett syndrome
7 August 2024 - Designation based on preliminary clinical evidence from ongoing NGN-401 clinical trial that shows potential to address unmet ...
Posted by Michael Wonder on 07 Aug 2024
Novartis receives FDA accelerated approval for Fabhalta (iptacopan), the first and only complement inhibitor for the reduction of proteinuria in primary IgA nephropathy
8 August 2024 - Fabhalta achieved a 44% proteinuria reduction from baseline in Phase 3 APPLAUSE-IgAN interim analysis, compared with 9% ...
Posted by Michael Wonder on 07 Aug 2024
George Medicines files new drug application with FDA for novel low dose triple combination for treatment of hypertension following successful international Phase 3 development program
6 August 2024 - Two international Phase 3 clinical trials for the treatment of hypertension, versus dual therapy and placebo, met ...