FDA Events Calendar

Track upcoming clinical trials, regulatory milestones, and biotech events

September 2026

302 events

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Tue

Wed

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Sat

1

envudeucitinib (ESK-001) - (LUMUS)Rhapsido (Remibrutinib) - (REMODEL-1)Halneuron - (HALT-CINP / HAL-CINP-203)

2

Ivonescimab (SMT112) with chemotherapy - (HARMONi-2)ACI-19764 Apitegromab - (FORGE)

3

Etentamig (ABBV-383) - (CERVINO)Bradykinin B2 receptor - (CHAPTER-1)YUTREPIA (treprostinil) inhalation powder - (RE-WARM)

4

pelacarsen - (Lp(a)HORIZON)ETCAMAH (Camizestrant) - (SERENA-6)ZANVASTRO (zilganersen)

5

6

EPX-100 - (ARGUS)ARIKAYCE - (ENCORE)GRI-0621-IPF-02

7

Azetukalner (XEN1101) - (X-TOLE2)

8

INBRX-106 with Keytruda (pembrolizumab)tozorakimab - (OBERON)GRI-0621-IPF-02

9

ORZEYFUL (Oveporexton (TAK-861-3001)) - (FirstLight)AX-0811 SER-252 (POZ-apomorphine) in combination with enFuse

10

DISC-3405 - (RESTORE-PV)PRT13722 HYRNUO (sevabertinib) - (SOHO-01)

11

Leniolisib - (pediactric)ISEMBYLD (apitegromab-mstn) - (SAPPHIRE)MTX240 (OPB-171775)

12

13

14

SION-719 - (PreciSION CF)AP-SA02 - (diSARM)KIMMTRAK with or without anti-PD1 therapy - (TEBE-AM)

15

Ebribafusp (AKB-097 (ADX-097))PH-762 AXPAXLI (OTX-TKI) - (SOL-1)

16

Ateganosine (THIO-101)FT839-101 - (COMPLETE)ONP-002 - (Australian trial)

17

Azetukalnerm - (X-ACKT)MAR002 FAYUVI (rebisufligene etisparvovec-hopf)

18

Inluriyo (imlunestrant) - (EMBER-3)lanreotide injection, 120 mg/0.5 mL Olanzapine LAI (44749) - (SOLARIS)

19

UX111 - (ABO-102)

20

21

WINREVAIR (sotatercept-csrk) - (HYPERION)WINREVAIR (sotatercept-csrk) - (HYPERION)

22

RAP-219 Zilganersen (ION373)

23

IMNN-001 - (OVATION 3)DT120 ODT (MM120) lysergide tartrate - (Panorama)IMNN-001 - (OVATION 3)

24

AXPAXLI (OTX-TKI) - (SOL-1)DURAVYU (EYP-1901) - (LUGANO)AXPAXLI (OTX-TKI) - (SOL-1)

25

GLIX1 Cemsidomide (CFT7455) in combination with Dexamethasone - (MOMENTUM)Tambiciclib (SLS009) (GFH009) with venetoclax

26

Zilurgisertib (INCB000928) - (PROGRESS)Zilurgisertib (INCB000928) - (PROGRESS)

27

Relutrigine (PRAX-562) - (EMBOLD)

28

CMP-002 (CMP-SYNGAP-01)Ameluz (aminolevulinic acid hydrochloride) topical gel in combination with the RhodoLED red-light lamp series

29

Zeleciment basivarsen (z-basivarsen) (DYNE-101) - (ACHIEVE)AL001-BD01 - (Lithium in Brain)Aglatimagene besadenovec (CAN-2409) - (ULYSSES)

30

Mim8 - (FRONTIER5)Eloralintide and tirzepatide - (eloraTZP)Retatrutide - (TRIUMPH)

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