Elite Pharmaceuticals, Inc.
https://www.elitepharma.com/
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Latest From Elite Pharmaceuticals, Inc.
Vanda Objects To FDA’s ‘Highly Prejudicial’ Hearing Process And ‘Extra-Regulatory’ Requirements
Vanda says FDA improperly requires it to disprove all alleged deficiencies in its Hetlioz application for jet lag. Contentious approach to notice of opportunity for hearing contrasts with that of Intarcia and Lexicon, which also seek hearings over FDA’s proposal to refuse their applications.
Keeping Track: Gilead Gets CRL For Bulevirtide, CytoDyn Withdraws Leronlimab; Eye and CNS Drug Submissions
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Santhera Finalizes Vamorolone Filings And Now Seeks Funds
The Swiss biotech is hoping that its Duchenne muscular dystrophy prospect, vamorolone, will get on the FDA fast track to approval but acknowledges that getting more funds is an urgent priority to prepare for a potential US launch.
Keeping Track: Furoscix, SPN-830 Show Difficulties Of Drug-Device Combinations
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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