Question 1

What upcoming FDA catalysts are there in CNS & Neurology?

Accepted Answer

pdufa.bio tracks 24 upcoming CNS & Neurology catalysts (8 PDUFA decisions, 16 trial readouts), each with a date and a primary-source link.

Question 2

What is the next CNS & Neurology FDA decision?

Accepted Answer

The next tracked PDUFA date in CNS & neurology is TEVA's IGALMI (dexmedetomidine sublingual film) - (SERENITY At-Home) for At-home agitation in bipolar disorder or schizophrenia (sNDA), with an FDA goal date of 2026-11-14.

Question 3

Which cns & neurology drugs have upcoming PDUFA dates?

Accepted Answer

IGALMI (dexmedetomidine sublingual film) - (SERENITY At-Home) (TEVA, 2026-11-14); Relutrigine (PRAX-562) - (EMBOLD) (PRAX, 2026-12-27); MR-107A-02 (fast-acting meloxicam) (VTRS, 2026-12-27); AD109 (Oxnimbi) - obstructive sleep apnea (APMD, 2027-02-28); LIBERVANT (diazepam) buccal film - ages 6 to 11 (Type 9 NDA) (ETON, 2027-03-29); Pitolisant GR (gastro-resistant formulation) - NDA (HRMY, 2027-04-01) and 2 more. Each links its source on this page.

Question 4

What cns & neurology clinical trial readouts are expected?

Accepted Answer

We track 16 upcoming CNS & neurology readouts; the nearest is IMUX's IMU-838 tablets 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No. We do not publish per-drug approval probabilities; we show verified facts, primary-source links, and historical base rates so you can judge for yourself.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 CNS & Neurology FDA decisions & readouts

PDUFA decisions (8)

Trial readouts (16)