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RSS FeedPosted by Michael Wonder on 03 Feb 2023
FDA approves sacituzumab govitecan-hziy for HR positive breast cancer
3 February 2023 - Today, the FDA approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences) for patients with unresectable locally advanced or ...
Posted by Michael Wonder on 02 Feb 2023
Tezspire approved for self-administration in the US with a new pre-filled pen
2 February 2023 - First and only respiratory biologic without phenotype or biomarker limitations that offers the choice of administration ...
Posted by Michael Wonder on 02 Feb 2023
FDA approves first oral treatment for anaemia caused by chronic kidney disease for adults on dialysis
1 February 2023 - Today, the US FDA approved Jesduvroq tablets (daprodustat) as the first oral treatment for anaemia caused by ...
Posted by Michael Wonder on 01 Feb 2023
FLAG Therapeutics receives rare paediatric disease designation for FLAG-003 for the treatment of children with diffuse intrinsic pontine glioma
31 January 2023 - FLAG Therapeutics announced today that FLAG-003, an investigational small molecule therapy for the treatment of diffuse intrinsic ...
Posted by Michael Wonder on 01 Feb 2023
Mesoblast resubmits biologic license application to FDA for remestemcel-L in children with steroid-refractory acute graft versus host disease
31 January 2023 - New 4 year data from the Phase 3 trial shows durable long term survival outcomes. ...
Posted by Michael Wonder on 01 Feb 2023
Trastuzumab deruxtecan for treating HER2 positive unresectable or metastatic breast cancer after one or more anti-HER2 treatments
1 February 2023 - Trastuzumab deruxtecan is recommended with managed access as an option for the treatment of adults with HER2 ...
Posted by Michael Wonder on 31 Jan 2023
Ionis receives FDA fast track designation for olezarsen in patients with familial chylomicronaemia syndrome
31 January 2023 - If approved, olezarsen would be the first approved treatment for familial chylomicronaemia syndrome in the US. ...
Posted by Michael Wonder on 31 Jan 2023
Reneo Pharmaceuticals receives fast track designation from the FDA for mavodelpar (REN001) in a genotype of long-chain fatty acid oxidation disorder
31 January 2023 - Reneo Pharmaceuticals today announced that the US FDA has granted mavodelpar (REN001) fast track designation for long ...
Posted by Michael Wonder on 31 Jan 2023
Amjevita (adalimumab-atto), first biosimilar to Humira, now available in the United States
31 January 2023 - Four years of real world experience in more than 300,000 patients and over 60 countries. ...
Posted by Michael Wonder on 31 Jan 2023
Association between pre-approval confirmatory trial initiation and conversion to traditional approval or withdrawal in the FDA accelerated approval pathway
27 January 2023 - The accelerated approval pathway allows the US FDA to approve drugs that demonstrate an effect on a ...
Posted by Michael Wonder on 31 Jan 2023
FDA may not always require post-approval trials to be enrolled before accelerated approvals
30 January 2023 - A FDa official on Monday gave more clues for how the agency plans to wield new authority ...
Posted by Michael Wonder on 31 Jan 2023
Medicare drug price negotiation in the United States: implications and unanswered questions
8 December 2022 - The United States is a relatively free pricing market for pharmaceutical manufacturers to set list prices at ...
Posted by Michael Wonder on 30 Jan 2023
Abbisko Therapeutics announces that US FDA has granted breakthrough therapy designation for its CSF-1R inhibitor pimicotinib (ABSK021)
30 January 2023 - Abbisko Therapeutics today announced that its CSF-1R inhibitor pimicotinib (ABSK021) has been granted breakthrough therapy designation ...
Posted by Michael Wonder on 30 Jan 2023
US law makers call on Biden Administration to lower the price of enzalutamide
27 January 2023 - US Senator Elizabeth Warren, a Democrat from Massachusetts, and nearly two dozen other lawmakers are demanding to ...
Posted by Michael Wonder on 30 Jan 2023
argenx receives notification of PDUFA date extension for SC efgartigimod
27 January 2023 - argenx today announced that the US FDA has extended the review of the biologics license application ...