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RSS FeedPosted by Michael Wonder on 03 Jul 2023
Organon & Samsung Bioepis announce US launch of Humira biosimilar Hadlima (adalimumab-bwwd) in multiple presentations consistent with originator
1 July 2023 - Individualised patient support program “Hadlima For You” available including co-pay support. ...
Posted by Michael Wonder on 03 Jul 2023
Cyltezo, first and only FDA approved interchangeable biosimilar to Humira, now commercially available in the US
1 July 2023 - Cyltezo is the only adalimumab biosimilar with Phase 3 comparative clinical studies in rheumatoid arthritis, plaque ...
Posted by Michael Wonder on 03 Jul 2023
Celltrion USA launches Yuflyma (adalimumab-aaty), a Humira (adalimumab) biosimilar, in the US
3 July 2023 - Celltrion USA today announced the launch of Yuflyma (adalimumab-aaty), a high concentration (100 mg/mL) and citrate-free formulation ...
Posted by Michael Wonder on 03 Jul 2023
Genentech withdraws use of Gavreto in US for a type of thyroid cancer, says partner Blueprint
30 June 2023 - Genentech will withdraw Gavreto from use in the US for treating a type of thyroid cancer ...
Posted by Michael Wonder on 03 Jul 2023
Celltrion applies for approval in US for eye treatment biosimilar
30 June 2023 - The biopharmaceutical company now covers ophthalmology as well as auto-immune disease and cancer medicine. ...
Posted by Michael Wonder on 01 Jul 2023
Sandoz to launch Hyrimoz (adalimumab-adaz) high concentration formulation, marking Sandoz entrance into US immunology space
1 July 2023 - Hyrimoz (adalimumab-adaz) high concentration formulation biosimilar offers US patients reduced injection volume in citrate free formulation. ...
Posted by Michael Wonder on 01 Jul 2023
Zealand Pharma submits new drug application to US FDA for dasiglucagon in congenital hyperinsulinism
30 June 2023 - Zealand Pharma today announced the submission of a new drug application to the US FDA for dasiglucagon ...
Posted by Michael Wonder on 01 Jul 2023
Madrigal Pharmaceuticals announces rolling submission of new drug application to US FDA seeking accelerated approval of resmetirom for the treatment of NASH with liver fibrosis
30 June 2023 - Madrigal expects to complete full submission of the new drug application in July 2023. ...
Posted by Michael Wonder on 30 Jun 2023
Formycon announces submission of the biologics license application for FYB203, an aflibercept biosimilar candidate to the US FDA
29 June 2023 - Formycon and its license partner Klinge Biopharma announce that the biologics license application for FYB203, a ...
Posted by Michael Wonder on 29 Jun 2023
Zenocutuzumab granted breakthrough therapy designation by the US FDA for the treatment of NRG1+ pancreatic cancer
29 June 2023 - Merus today announced that the US FDA has granted breakthrough therapy designation for zenocutuzumab for the ...
Posted by Michael Wonder on 29 Jun 2023
Italfarmaco Group completes FDA submission of new drug application for givinostat in Duchenne muscular dystrophy and receives priority review
29 June 2023 - Submission based on completed Phase 3 program in 179 boys demonstrating significant slowing of disease progression with ...
Posted by Michael Wonder on 29 Jun 2023
Alvotech provides regulatory update on second biologics license application for AVT02
28 June 2023 - Alvotech announced today that the US FDA has issued a complete response letter for Alvotech’s second biologics ...
Posted by Michael Wonder on 29 Jun 2023
Eton Pharmaceuticals receives complete response letter for dehydrated alcohol injection
28 June 2023 - Eton Pharmaceuticals announced today that the US FDA issued a complete response letter in response to its ...
Posted by Michael Wonder on 29 Jun 2023
Genprex receives US FDA fast track designation for Reqorsa immunogene therapy in combination with Tecentriq for the treatment of small cell lung cancer
28 June 2023 - Third FDA fast track designation further validates the potential of Reqorsa. ...
Posted by Michael Wonder on 28 Jun 2023
FDA approves Pfizer’s Ngenla, a long-acting once weekly treatment for paediatric growth hormone deficiency
28 June 2023 - New, longer-acting treatment offers option to reduce the frequency of injections for children with growth hormone ...