FDA Events Calendar

Track upcoming clinical trials, regulatory milestones, and biotech events

November 2026

176 events

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1

Mitapivat (AG-348) - (RISE UP)

2

BMB-101 - (BREAKTHROUGH)INTERCEPT - (RedeS)FILSPARI (sparsentan) - (SPARTAN)

3

SAR448272/NX-3911 REC-4881 - (TUPELO)IBSRELA (tenapanor) - (ACCEL)

4

EVO570 (formerly HC118)Nexiguran Ziclumeran (nex-z) - (MAGNITUDE-2)Sovleplenib - (China trial)

5

ATTO-1310 Atacicept - (PIONEER)ADI-212

6

RYBREVANT FASPRO (subcutaneous amivantamab and hyaluronidase-lpuj with Halozyme’s ENHANZE) - ( OrigAMI-4)MiNK-215 + agenT-797 forazapadin (SAT-3247 (CL-101)) - (BASECAMP)

7

IMNN-001 - (OVATION 2)ALG-170675 PH-762

8

NKX019 - (Ntrust-2)elebsiran (VIR-2218) and tobevibart (VIR-3434) - (SOLSTICE)Retatrutide (LY3437943) - (TRIUMPH-4)

9

Pemvidutide - (RECLAIM)Seladelpar - (IDEAL)Nexiguran Ziclumeran (nex-z)

10

Obecabtagene autoleucel (CARLYSLE)KETAFREE

11

Lenacapavir compared with emtricitabine/tenofovir disoproxil fumarate (F/TDF) - (PURPOSE-5)Taltz (ixekizumab) and Zepbound (tirzepatide) - (TOGETHER-PsA)Lenacapavir compared with emtricitabine/tenofovir disoproxil fumarate (F/TDF) - (PURPOSE-5)

12

Nomlabofusp (CTI-1601)Bezisterim (NE3107) - (ADDRESS-LC)

13

NEO100 rexaceract (GT-02287)NEO212

14

Eftilagimod alpha (IMP321) and KEYTRUDA (pembrolizumab) - (TACTI-003)IGALMI® (dexmedetomidine) - (SERENITY III)Ivonescimab plus platinum-doublet chemotherapy - (HARMONi)

15

cretostimogene - (PIVOT-006) (EAP)Plamotamab Navenibart (STAR-0215) - (ALPHA-SOLAR)

16

VY1706 Remlifanserin (ACP-204) - (RADIANT)

17

Remlifanserin (ACP-204) - (RADIANT)CagriSema - (REDEFINE 9)NEO212

18

IPH4502 AL001-BD01 - (Lithium in Brain)

19

Eftilagimod alpha with pembrolizumab and radiotherapy - (EFTISARC-NEO)micvotabart pelidotin (PYX-201-101) - (MICVO)micvotabart pelidotin (PYX-201-101) - (MICVO)

20

Rezatapopt (PC14586) - (PYNNACLE)ACR-2316 IM1240 - (CAPTN-3)

21

22

Deramiocel (CAP-1002) - (HOPE-3)Deramiocel (CAP-1002) - (HOPE-3)MOLBREEVI (Molgradex) - (IMPALA-2)

23

24

DM199 (rinvecalinase alfa)

25

26

27

BBP-418 - (FORTIFY)Neladalkib (NVL-655) - (ALKove-1)BBP-418 - (FORTIFY)

28

D-PLEX100 - (SHIELD II)D-PLEX100 - (SHIELD II)D-PLEX100 - (SHIELD II)

29

30

Bezuclastinib and SUTENT (sunitinib) - (PEAK)ATEV V012 NPM-139 - (SLIM-1)

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