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Swedish Orphan Biovitrum AB
2 articles
Biovitrum Shares Fall 3% After FDA Decline
FDA issued a Complete Response Letter rejecting Sobi’s NASP gout therapy due to manufacturing and CMC deficiencies, without safety concerns.
Sobi’s stock fell about 2.5% to SEK454.5, underperforming t
Biovitrum Falls 3% After FDA Rejects Gout
Shares of Swedish Orphan Biovitrum AB fell 3% to SEK454.5 after FDA issued a Complete Response Letter rejecting its gout therapy NASP.
FDA's letter cited chemistry, manufacturing and controls deficien