FDA rejection

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Pharma

Xspray's Dasynoc knocked back by FDA over production once again

Less than a year after the FDA turned down the filing for its leukemia prospect Dasynoc, Xspray Pharma has again hit a wall at the U.S. regulator.
Fraiser Kansteiner Aug 20, 2026 2:50pm
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FDA halts release of new drug rejection letters

Jul 8, 2026 1:33pm
Gilead

Gilead's once-rejected hepatitis D med wins FDA nod

May 26, 2026 9:49am
rejected document

Citizen petition calls on FDA to tighten up CRL disclosures

Apr 23, 2026 11:26am
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Shedding 60% of workforce, Replimune vows to continue operations

Apr 21, 2026 2:15am
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Replimune to lay off staff after 'disappointing' second rejection

Apr 10, 2026 1:56pm