FDA Reversal Gives Amicus Renewed Hope For US Oral Fabry Launch
Amicus plans to file migalastat for Fabry disease in the US in the fourth quarter, after FDA gave the greenlight, reversing a decision last year to require an additional Phase III study.
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Amicus' Oral Fabry Drug Priced To Compete Against Traditional ERT
FDA approved Galafold under accelerated approval, paving the way for the launch of the first oral therapy to treat a subset of patients with the rare condition Fabry disease. Amicus priced Galafold at $315,000 per year.
14 Approvals To Look Out For In Q3
As many as 14 new products are up for US approval in the third quarter, research by Informa Pharma's Biomedtracker shows. Scrip takes a look at the candidates and their chances of reaching the market.
FDA Reversal Puts Alkermes Depression Drug Back On Track For January Approval
Reversing an earlier decision, FDA accepted Alkermes' new drug application (NDA) for ALKS 5461 for review, with a target action date of Jan. 31. But the company could still face a tough FDA review.