DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)
Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) The FDA approved it on Jan 27, 2026. 2 FDA decisions on record below. Every date links its source.
We track 2 catalyst events for this program: 0 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
When is DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)'s next FDA decision or readout?
No upcoming catalyst is on our calendar for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj); 2 FDA decisions are on record below.
What happened at DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)'s most recent FDA decision?
On Jan 27, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
Has DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) been approved by the FDA?
Yes. The FDA approved an application for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) on Jan 27, 2026; the decision page linked above carries the source.
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
and company filings. pdufa.bio is not affiliated with the FDA.
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