NME Approval Decline Likely To Continue In 2002: Only Two Filed This Year
• By The Pink Sheet
FDA has received only two NDAs for new molecular entities so far in 2002, Office of New Drugs Director John Jenkins, MD, told UBS Warburg's specialty pharma conference in New York City June 6
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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