FDA Events Calendar

Track upcoming clinical trials, regulatory milestones, and biotech events

September 2026

382 events

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Sat

1

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

2

GTX-102 - (Aspire)RASONQUE (Daraxonrasib (RMC-6236)0 Paxalisib

3

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

4

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

5

6

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

7

Azetukalner (XEN1101) - (X-TOLE2)

8

INBRX-106 with Keytruda (pembrolizumab)DT120 ODT (Lysergide (LSD)) - (Emerge)GRI-0621-IPF-02

9

CT-202 ORZEYFUL (Oveporexton (TAK-861-3001)) - (FirstLight)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

KIMMTRAK with or without anti-PD1 therapy - (TEBE-AM)JNJ-5120/PIPE-307 - (MOONLIGHT-1)SION-719 - (PreciSION CF)

15

PH-762 Rademikibart - (Seabreeze STAT Asthma)SERP-01

16

ONP-002 - (Australian trial)FT819 - (RECLAIM-LN)FT839-101 - (COMPLETE)

17

azetukalner (XEN1101) - (X-NOVA)Alisertib - (PUMA-ALI-4201) in combination with paclitaxel - (ALISCA-Lung2)Azetukalnerm - (X-ACKT)

18

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

19

UX111 - (ABO-102)

20

21

AP-SA02 - (diSARM)OST-HER2 (AOST-2121)CUE-221 (UB-221)

22

paxalisib Crofelemer Tegoprubart (AT-1501) - (BESTOW)

23

IMVT-1402 (imeroprubart)NHBE GalNAc siRNA (WVE-007) - (INLIGHT)ACI-7104.056 - (VacSYn)

24

AVC-203 - (QUADvance)AVC-201 - (RevSTAR-123)NXP200

25

Ifinatamab deruxtecan (DS-7300) - (IDeate-Lung01 )Olumiant (baricitinib) - (BRAVE-AA-PEDS)Atebrioz (zilurgisertib) - (PROGRESS)

26

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

27

Relutrigine (PRAX-562) - (EMBOLD)

28

Nasal Foralumab - (Healey ALS)JUVMO (tavapadon) - (TEMPO-2)MN-001 (Tipelukast) - (NATG-202)

29

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

30

SRP-4045 + SRP-4053 (ESSENCE)Ruxolitinib Cream - (TRuE-AD4)Povorcitinib (INCB054707) - (STOP-HS)

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