Amicus Therapeutics, Inc.
http://www.amicusrx.com/
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Latest From Amicus Therapeutics, Inc.
Scrap Citizen Petition Proposal For 505(b)(2), Off-Patent Industry Urges FDA
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.
October Outlook For US FDA Approvals: Goal Dates Are Sparse, But Backlog Looms
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.
Sanofi Bags EU Approvals But Fumes At Regulator
Although Nexviadyme has been approved, the French group is still unhappy about the EMA's view that the Pompe disease therapy should not be classified as a new active substance.
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Biotechnology
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Drug Discovery Tools
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Drug Discovery Tools
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