FDA refuses Zogenix’s seizure drug Fintepla
The company did not submit certain non-clinical studies to allow the FDA to assess chronic administration of the drug.
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Tag: refusal to file
FDA turns away filing for Celgene’s MS drug
US regulators are refusing to file Celgene’s application to market its experimental multiple sclerosis therapy ozanimod.
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- Laigo Bio completes final close of €17m seed financing round
- Axplora announces expansion as newest part of $60m API investment programme
- DNA Script signs SYNTAX distribution agreements with Gencell, BMS and Biostream
- Ondine’s Steriwave phase 3 trial reaches 93% enrolment milestone
- Arvinas reports strong phase 1 results for ARV-102 in Parkinson’s disease
