Hereditary Transthyretin-mediated Amyloidosis with Polyneuropathy
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EMA approval · 2025-11-05EMA Authorised: Beyonttra (acoramidis hydrochloride) — Bayer AG
The European Medicines Agency authorised Beyonttra (acoramidis hydrochloride) by Bayer AG for hereditary transthyretin-mediated amyloidosis …
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EMA approval · 2025-08-13EMA Authorised: Amvuttra (vutrisiran sodium) — Alnylam Netherlands B.V.
EMA authorised Amvuttra (vutrisiran) for hereditary transthyretin-mediated amyloidosis with polyneuropathy (familial amyloid neuropathy).
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FDA approval · 2025-03-11FDA Approved: AMVUTTRA — Supplemental Application (Alnylam Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Amvuttra (vutrisiran) submitted by Alnylam Pharmaceuticals, reflecting a regulatory update t…
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FDA approval · 2023-01-13FDA Approved: ONPATTRO — Supplemental Application (Alnylam Pharmaceuticals, Inc.)
The FDA approved a supplemental application for ONPATTRO (patisiran) from Alnylam Pharmaceuticals, reflecting a regulatory action to modify …
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FDA approval · 2022-10-03FDA Approved: ONPATTRO — Supplemental Application (Alnylam Pharmaceuticals, Inc.)
FDA approved a supplemental application for ONPATTRO (patisiran) by Alnylam Pharmaceuticals.
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FDA approval · 2022-06-13FDA Approved: AMVUTTRA — Original Application (Alnylam Pharmaceuticals, Inc.)
The FDA approved AMVUTTRA (vutrisiran) from Alnylam Pharmaceuticals for hereditary transthyretin-mediated amyloidosis with polyneuropathy. T…
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FDA approval · 2020-04-17FDA Approved: ONPATTRO — Supplemental Application (Alnylam Pharmaceuticals, Inc.)
The FDA approved a supplemental application for ONPATTRO (patisiran) from Alnylam Pharmaceuticals.
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FDA approval · 2019-09-16FDA Approved: ONPATTRO — Supplemental Application (Alnylam Pharmaceuticals, Inc.)
The FDA approved a supplemental application for ONPATTRO (patisiran) submitted by Alnylam Pharmaceuticals, Inc., indicating an update to its…
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FDA approval · 2019-05-06FDA Approved: ONPATTRO — Supplemental Application (Alnylam Pharmaceuticals, Inc.)
The FDA approved a supplemental application for ONPATTRO (patisiran) submitted by Alnylam Pharmaceuticals.
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FDA approval · 2018-08-10FDA Approved: ONPATTRO — Original Application (Alnylam Pharmaceuticals, Inc.)
The FDA approved ONPATTRO (patisiran) as the original application for hereditary transthyretin-mediated amyloidosis with polyneuropathy, dev…