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33 results
8:38 AM, Mar 30, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Japan approvals include Hemlibra, Shingrix Galafold

plans to launch the drug "in the coming months." Galafold, a small molecule stabilizer of alpha galactosidase
5:04 AM, Feb 16, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Priority Review for Amicus' migalastat

Migalastat has Orphan Drug and Fast Track designations from FDA. The small molecule stabilizer of alpha galactosidase
11:47 AM, Dec 15, 2017  |  BC Week In Review | Clinical News  |  Regulatory

Amicus submits NDA for Fabry candidate

the basis for accelerated approval (see BioCentury, July 14 ). The small molecule stabilizer of alpha galactosidase
12:31 PM, Jul 14, 2017  |  BC Week In Review | Clinical News  |  Regulatory

FDA clears Amicus to submit migalastat NDA without new trial

patient access scheme (see BioCentury, March 6 ). Migalastat is a small molecule stabilizer of alpha galactosidase
12:00 AM, Jun 06, 2016  |  BC Week In Review | Clinical News  |  Regulatory

Galafold migalastat regulatory update

disease but did not give a specific price. Galafold is a small molecule that enhances alpha galactosidase
12:00 AM, Apr 11, 2016  |  BC Week In Review | Clinical News  |  Regulatory

Galafold migalastat regulatory update

said it would delay submitting an NDA to FDA for the small molecule that enhances alpha galactosidase
12:00 AM, Oct 05, 2015  |  BC Week In Review | Clinical News  |  Regulatory

Migalastat regulatory update

the agency, the biotech will evaluate “several U.S. pathways” for the small molecule that enhances alpha galactosidase
12:00 AM, Jul 13, 2015  |  BC Week In Review | Clinical News  |  Regulatory

Galafold migalastat regulatory update

submit an NDA to FDA and seek accelerated approval for the small molecule that enhances alpha galactosidase
12:00 AM, Jun 15, 2015  |  BC Week In Review | Clinical News  |  Regulatory

Galafold migalastat regulatory update

submit an NDA to FDA and seek accelerated approval for the small molecule that enhances alpha galactosidase
12:00 AM, Jun 01, 2015  |  BC Week In Review | Clinical News  |  Regulatory

Amigal migalastat regulatory update

submit an NDA to FDA and seek accelerated approval for the small molecule that enhances alpha galactosidase

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