Question 1

What upcoming FDA catalysts are there in Hematology?

Accepted Answer

pdufa.bio tracks 18 upcoming Hematology catalysts (4 PDUFA decisions, 14 trial readouts), each with a date and a primary-source link.

Question 2

What is the next Hematology FDA decision?

Accepted Answer

The next tracked PDUFA date in hematology is NVO's Mim8 (denecimig) for Hemophilia A prophylaxis, with or without inhibitors, with an FDA goal date of 2026-12-31.

Question 3

Which hematology drugs have upcoming PDUFA dates?

Accepted Answer

Mim8 (denecimig) (NVO, 2026-12-31); Mitapivat (PYRUKYND) - (RISE UP) (AGIO, 2027-02-01); Reblozyl (luspatercept) with a JAK inhibitor - myelofibrosis-associated anemia (INDEPENDENCE) (BMY, 2027-03-11); Mezigdomide + carfilzomib + dexamethasone - RRMM (SUCCESSOR-2) (BMY, 2027-05-13). Each links its source on this page.

Question 4

What hematology clinical trial readouts are expected?

Accepted Answer

We track 14 upcoming hematology readouts; the nearest is BYSI's Plinabulin around Nov 2026 (est.). Readout dates are estimates from trial registries and company guidance, and they shift.

Question 5

Does pdufa.bio predict whether these will be approved?

Accepted Answer

No. We do not publish per-drug approval probabilities; we show verified facts, primary-source links, and historical base rates so you can judge for yourself.

Upcoming Hematology FDA decisions & readouts

PDUFA decisions (4)

Trial readouts (14)