What upcoming FDA catalysts are there in Hematology?

pdufa.bio tracks 8 upcoming Hematology catalysts (0 PDUFA decisions, 8 trial readouts), each with a date and a primary-source link.

Does pdufa.bio predict whether these will be approved?

No. We do not publish per-drug approval probabilities; we show verified facts, primary-source links, and historical base rates so you can judge for yourself.

pdufa.bio

Calendar Decisions Readouts Run-up Stocks

Drug Index Conferences Advisory Committees Screener Research API SLS tracker Account

Pro

Home › Condition › Hematology

Upcoming Hematology FDA decisions & readouts

Updated August 7, 2026·next FDA decision on the calendar

PDUFA target dates and trial readouts in hematology, each linked to its primary source. Updated from FDA/SEC/ClinicalTrials.gov; dates can shift.

Cancer & Oncology Obesity & Metabolic CNS & Neurology Immunology & Inflammation Cardiovascular Rare Disease Infectious Disease & Vaccines Ophthalmology & Eye

Trial readouts (8)

AGIO · Jun 2026 (est.)

Mitapivat: Anemia

CERS · Jul 2026 (est.)

S-303 Treated Red Blood Cells: Anemia

AKBA · Aug 2026 (est.)

Vadadustat: Anemia of Chronic Kidney Disease

KPTI · Sep 2026 (est.)

Selinexor: Myelofibrosis

CSLLY · Oct 2026 (est.)

Recombinant Single-Chain Factor Viii: Congenital Hemophilia A

GERN · Feb 2027 (est.)

Imetelstat: Myelofibrosis

IRON · Jun 2027 (est.)

DISC-1459: Sickle Cell Disease

KPTI · Jun 2027 (est.)

Selinexor: Myelofibrosis

We don't show an approval percentage for these hematology catalysts. Here's why.