Amicus Therapeutics, Inc.
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Latest From Amicus Therapeutics, Inc.
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
Several stakeholders across the off-patent industry, including trade groups and manufacturers, have encouraged the FDA to scrap its proposal to require companies to submit citizen petitions for requesting therapeutic equivalence evaluations for 505(b)(2) applications.
Upcoming user fee goal dates include AstraZeneca’s tremelimumab, Amicus’ AT-GAA, and drug delivery technology-driven NDAs from Supernus/US Worldmeds and scPharmaceuticals
Coming Up On US FDA’s User Fee Calendar: Zynteglo Approval Kicks Off Busy Season For Advanced Biologics, Pediatrics
At least 17 applications are pending with late August and September 2022 user fee goal dates, the Pink Sheet US FDA Performance Tracker shows.
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