4 December 2023 - Celltrion announced on 30 November (local time) that it has completed the application for product licensing ...
30 November 2023 - Formycon and its commercialisation partner Fresenius Kabi today announced that the US FDA has accepted the biologics ...
17 November 2023 - Forteo (teriparatide injection) is indicated to treat osteoporosis among certain women and men.
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7 November 2023 - Supplemental biologics license application based on Phase 4 study which assessed pharmacokinetic similarity between two treatment groups: ...
31 October 2023 - Today, US Department of Health and Human Services Secretary Xavier Becerra released the following statement regarding ...
31 October 2023 - Today, the US FDA approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) ...
22 October 2023 - Zymfentra is the first and only FDA approved subcutaneous formulation of infliximab approved for the maintenance treatment ...
12 October 2023 - Alvotech announced today that the US FDA has issued a complete response letter for Alvotech’s biologics ...
7 October 2023 - The US FDA has issued a complete response letter for the biologics license application for insulin aspart. ...
5 October 2023 - Interchangeable designation supported by positive data from the REFLECTIONS B538-12 study. ...
5 October 2023 - Resubmission follows the satisfactory resolution of the FDA’s review of inspection findings at the third-party filler. ...
2 October 2023 - Adalimumab-adbm will be priced at an 81% discount to Humira (adalimumab). ...
29 September 2023 - Tofidence (BIIB800) becomes the first tocilizumab biosimilar to gain FDA approval in the US. ...
25 September 2023 - No issues with clinical efficacy or safety, trial design, labeling, drug substance manufacturing, or device design or ...
20 September 2023 - Alvotech announced today that the US FDA has accepted Alvotech’s resubmitted biologics license application for AVT02, a ...