United States — Food and Drug Administration & Astellas Pharma
2 shared events · Importance 3 · Last updated Jun 27, 2026
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Regulatory
United States — Food and Drug Administration: The United States — Food and Drug Administration granted tentative approval for Lupin (company)'s Enzalutamide Tablets, acting as the regulatory body overseeing drug approvals in the U.S.
Astellas Pharma: Astellas Pharma is the manufacturer of the reference listed drug Xtandi Tablets, to which Lupin (company)'s Enzalutamide Tablets were found bioequivalent. This approval could introduce competition for Astellas Pharma's product.
Jun 26, 2026 · 16 articles
Business
United States — Food and Drug Administration: The United States — Food and Drug Administration has granted various designations to MiNK Therapeutics' programs and is involved in the approval pathway for its Fabry gene therapy.
Astellas Pharma: Astellas Pharma has licensed MiNK Therapeutics' STAC-BBB platform for neurological targets, indicating a past business relationship that could be affected by Sangamo's strategic review.
Jun 08, 2026 · 7 articles
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