How many FDA PDUFA decisions are scheduled for February 2027?

pdufa.bio currently tracks 10 FDA PDUFA decisions with dates in February 2027, each linked to a primary source. The list updates as new filings appear and dates shift.

What is a PDUFA date?

A PDUFA date is the FDA's goal date to decide on a drug application under the Prescription Drug User Fee Act.

Does pdufa.bio predict whether these will be approved?

No. We do not publish per-drug approval probabilities.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

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Home › Calendar › February 2027

February 2027 FDA PDUFA decisions

Page updated November 5, 2026·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET

PDUFA target dates for February 2027, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.

← January 2027 March 2027 →

10 PDUFA dates

AGIO · 2027-02-01

Mitapivat (PYRUKYND) goal date moved from Nov 1, 2026

GILD · 2027-02-02

Yeztugo (lenacapavir) once-weekly oral

BBIO · 2027-02-04

Oral infigratinib - achondroplasia in children (PROPEL 3): Rare Disease

RHHBY · 2027-02-09

Lunsumio VELO (mosunetuzumab) + Polivy - relapsed/refractory LBCL (SUNMO): Oncology

BLTE · 2027-02-12

Tinlarebant - Stargardt disease type 1: Ophthalmology

ARQT · 2027-02-23

ZORYVE (roflumilast) cream 0.05%

CGEM · 2027-02-27

Zipalertinib (CLN-081): relapsed EGFR exon 20 insertion NSCLC

APMD · 2027-02-28

AD109 (Oxnimbi): CNS/Neurology

BMRN · 2027-02-28

VOXZOGO (vosoritide): Rare Disease

PVLA · 2027-02-28

QTORIN rapamycin - microcystic lymphatic malformations (SELVA): Rare Disease

Looking for an approval probability for these? We deliberately don't publish one. Here's why, and what we show instead (verified history + base rates).

Companies on this page

Every company listed above, with its full catalyst history, past FDA decisions and measured run-up into each one.

AGIO APMD ARQT BBIO BLTE BMRN CGEM GILD PVLA RHHBY