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RSS FeedPosted by Michael Wonder on 15 Aug 2024
UroGen submits completed UGN-102 NDA seeking approval as the first FDA approved treatment for low grade intermediate risk non-muscle invasive bladder cancer
14 August 2024 - UroGen Pharma today announced the successful completion of its new drug application submission for investigational drug UGN-102, ...
Posted by Michael Wonder on 14 Aug 2024
Gilead’s Livdelzi (seladelpar) granted accelerated approval for primary biliary cholangitis by US FDA
14 August 2024 - First and only treatment to demonstrate statistically significant reductions across key biomarkers, ALP normalisation and pruritus versus ...
Posted by Michael Wonder on 14 Aug 2024
FDA approves axatilimab-csfr for chronic graft versus host disease
14 August 2024 - Today, the FDA approved axatilimab-csfr (Niktimvo, Incyte), a colony stimulating factor-1 receptor-blocking antibody, for the treatment ...
Posted by Michael Wonder on 14 Aug 2024
FDA approves new drug for hypoparathyroidism, a rare disorder
9 August 2024 - The US FDA has approved Yorvipath (palopegteriparatide) injection for subcutaneous use in adults with hypoparathyroidism. ...
Posted by Michael Wonder on 14 Aug 2024
The FDA should withdraw approval of more than 400 tainted medicines
12 August 2024 - When the FDA learned that a testing facility in India had submitted fraudulent data for more ...
Posted by Michael Wonder on 14 Aug 2024
Galderma receives US FDA approval for Nemluvio (nemolizumab) for adult patients living with prurigo nodularis
13 August 2024 - The US FDA granted Nemluvio priority review for the treatment of prurigo nodularis in February 2024, following ...
Posted by Michael Wonder on 13 Aug 2024
Insignis Therapeutics receives FDA fast track designation for IN-001 for anaphylaxis treatment
13 August 2024 - Convenient, needle-free, and simple to use liquid epinephrine sublingual spray. ...
Posted 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 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 ...