FDA sets August decision date for Provention’s type 1 diabetes drug
Shares in Provention Bio cratered last July when the FDA turned down its marketing application for type 1 diabetes therapy teplizumab. Armed with new data […]
Shares in Provention Bio cratered last July when the FDA turned down its marketing application for type 1 diabetes therapy teplizumab. Armed with new data […]
The FDA indicated something was not well with Provention Bio’s filing for type 1 diabetes therapy teplizumab in April when it delayed its review. Now, […]
Provention Bio needs to show the FDA that the drug substance produced from its contract manufacturer is comparable to the Eli Lilly-made drug substance that […]
Seelos’ SLS-005 (Trehalose) Receives EC’s Orphan Drug Designation to Treat Amyotrophic Lateral Sclerosis Published: May 28, 2021 | Tags: Seelos, SLS-005, Trehalose, EC, Orphan Drug […]
Shots: EMDAC has voted 10-7, confirming that the benefits of teplizumab outweigh the risks supporting the approval to delay T1D Mellitus The recommendation is based […]
The FDA says it has uncovered “deficiencies” in the marketing application for Provention Bio’s much-anticipated drug teplizumab for the prevention of type 1 diabetes (T1D) […]
Almirall and Tyris Collaborate to Develop Next Generation Gene Therapies Published: Jan 7, 2020 | Tags: Almirall, Tyris, Collaborate, Develop, Next Generation, Gene Therapies Sarepta […]
Shots: The BLA for teplizumab to delay or prevention of clinical T1D in at-risk individuals has been filed to the US FDA. The FDA has […]
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