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FDA Approvals Archive

Updated ·next FDA decision on the calendar

This page lists 89 FDA approvals covering February 2026 to July 2026. Each one links the FDA approval notice or the company filing that announced it.

Not inferred from price. This page lists 89 decision(s) whose outcome was read from a document rather than from the share-price reaction. 0 of them link that document; the rest are older entries we have not yet gone back and sourced, and we would rather say so than call them all verified. A further 0 record(s) in our archive have their outcome inferred from the share-price reaction rather than read from a filing, and they are deliberately not listed under a heading that asserts what the FDA did. They remain in the full archive, labelled unverified. We published one such inference that turned out to be impossible; see corrections.
FDA drug approvals with the decision-day move and run-up history; source-linked where verified. Labels under active validation; cross-check filings.
Browse: ✓ Approvals  ·  ✗ Complete Response Letters
2026 · 15
ARQT · 2026-06-30
Approved: ZORYVE (roflumilast) Cream 0.3
VRDN · 2026-06-29
Approved: Lumvoa (veligrotug-vvze) - (TH
ABBV · 2026-06-26
Approved: SKYRIZI (risankizumab-rzaa)
VRDN · 2026-06-26
Approved: Lumvoa (veligrotug-vvze) - (TH
PFE · 2026-06-24
Approved: IBRANCE (palbociclib) in combi
IONS · 2026-06-24
Approved: TRYNGOLZA (olezarsen) - (CORE)
GILD · 2026-06-24
Approved: Trodelvy (sacituzumab goviteca
MRK · 2026-06-24
Approved: Trodelvy (sacituzumab goviteca
MRK · 2026-06-18
Approved: CAPVAXIVE (Pneumococcal 21-val
GSK · 2026-06-17
Approved: Utebzi (Tebipenem HBr) - (PIVO
SPRO · 2026-06-17
Approved: Utebzi (Tebipenem HBr) - (PIVO
ABBV · 2026-06-16
Approved: JUVÉDERM - (SKINVIVE) (injecta
BAYRY · 2026-06-15
Approved: AMBELVIST (gadoquatrane)
MRK · 2026-06-12
Approved: KEYTRUDA (pembrolizumab) and K
AZN · 2026-06-12
Approved: TRUQAP (capivasertib) in combi
LLY · 2026-06-09
Approved: EBGLYSS (lebrikizumab-lbkz) -
PFE · 2026-06-08
Approved: HYMPAVZI (marstacimab)
XOMA · 2026-06-08
Approved: MIPLYFFA (MY-PLY-FAH) (arimocl
LGND · 2026-06-08
Approved: MIPLYFFA (MY-PLY-FAH) (arimocl
ZVRA · 2026-06-08
Approved: MIPLYFFA (MY-PLY-FAH) (arimocl
AMRX · 2026-06-04
Approved: Romidepsin injection solution,
BMY · 2026-06-01
Approved: Camzyos (mavacamten) - (SCOUT-
JNJ · 2026-05-29
Approved: TREMFYA (guselkumab)
MNKD · 2026-05-29
Approved: Afrezza (Technosphere Insulin)
AZN · 2026-05-28
Approved: Imfinzi (durvalumab)
IRWD · 2026-05-27
Approved: LINZESS (Iinaclotide)
ABBV · 2026-05-27
Approved: LINZESS (Iinaclotide)
PGEN · 2026-05-27
Approved: PAPZIMEOS (zopapogene imadenov
GILD · 2026-05-26
Approved: Hepcludex (Bulevirtide) - (MYR
AZN · 2026-05-22
Approved: Datopotamab Deruxtecan (Dato-D
AZN · 2026-05-18
Approved: BAXFENDY (baxdrostat)
SPRY · 2026-05-15
Approved: Neffy 1 mg (epinephrine nasal
AZN · 2026-05-15
Approved: ENHERTU (trastuzumab deruxteca
ONC · 2026-05-13
Approved: BEQALZI (Sonrotoclax)
ARGX · 2026-05-08
Approved: VYVGART - (ADAPT SERON)
ADMA · 2026-05-04
Approved: ASCENIV (RI-002)
PFE · 2026-05-01
Approved: VEPPANU (vepdegestrant) - (VER
ARVN · 2026-05-01
Approved: VEPPANU (vepdegestrant) - (VER
INCY · 2026-05-01
Approved: Jakafi XR (ruxolitinib)
AXSM · 2026-04-30
Approved: AUVELITY (dextromethorphan HBr
JAGX · 2026-04-29
Approved: Canalevia-CA1
AZN · 2026-04-28
Approved: BREZTRI AEROSPHERE (budesonide
AZN · 2026-04-27
Approved: SAPHNELO (anifrolumab-fnia)
REGN · 2026-04-23
Approved: Otarmeni (lunsotogene parvec-c
REGN · 2026-04-22
Approved: DUPIXENT (dupilumab) - (LIBERT
SNY · 2026-04-22
Approved: DUPIXENT (dupilumab) - (LIBERT
MRK · 2026-04-21
Approved: IDVYNSO (doravirine/islatravir
LGND · 2026-04-13
Approved: FILSPARI (sparsentan)
TVTX · 2026-04-13
Approved: FILSPARI (sparsentan)
ANIP · 2026-04-08
Approved: Isosorbide Mononitrate Tablet
REGN · 2026-04-02
Approved: EYLEA HD (aflibercept) - (PHOT
LLY · 2026-04-01
Approved: Foundayo (orforglipron) - (ATT
IONS · 2026-03-30
Approved: SPINRAZA (Nusinersen) - (DEVOT
BIIB · 2026-03-30
Approved: SPINRAZA (Nusinersen) - (DEVOT
TEVA · 2026-03-30
Approved: PONLIMSI (denosumab-adet) (bio
RCKT · 2026-03-27
Approved: KRESLADI (marnetegragene autot
NVO · 2026-03-26
Approved: Awiqli (insulin icodec-abae) i
DNLI · 2026-03-25
Approved: AVLAYAH (Tividenofusp alfa) -
CORT · 2026-03-25
Approved: Lifyorli (relacorilant) plus A
RYTM · 2026-03-20
Approved: IMCIVREE (setmelanotide)
BMY · 2026-03-20
Approved: Opdivo in combination with AVD
GSK · 2026-03-19
Approved: Linerixibat - (GLISTEN)
NVO · 2026-03-19
Approved: Wegovy HD
JNJ · 2026-03-18
Approved: ICOTYDE (icotrokinra)
PTGX · 2026-03-18
Approved: ICOTYDE (icotrokinra)
GSK · 2026-03-13
Approved: Arexvy
NVS · 2026-03-13
Approved: COSENTYX (secukinumab)- (SUNSH
LNTH · 2026-03-06
Approved: PYLARIFY TruVu (piflufolastat
BMY · 2026-03-06
Approved: Sotyktu (deucravacitinib) - (P
HALO · 2026-03-05
Approved: TECVAYLI (teclistamab-cqyv) an
JNJ · 2026-03-05
Approved: TECVAYLI (teclistamab-cqyv) an
NVO · 2026-03-03
Approved: Sogroya (somapacitan) - (REAL8
ASND · 2026-02-27
Approved: YUVIWEL (navepegritide)
BMRN · 2026-02-27
Approved: PALYNZIQ (pegvaliase-pqpz) - (
AMPH · 2026-02-24
Approved: Ipratropium Bromide HFA Inhala
PFE · 2026-02-24
Approved: BRAFTOVI (encorafenib) in comb
RHHBY · 2026-02-20
Approved: CALQUENCE plus venetoclax
VNDA · 2026-02-20
Approved: Bysanti (milsaperidone)
HRMY · 2026-02-17
Approved: WAKIX (pitolisant)
EBS · 2026-02-13
Approved: OTC NARCAN Nasal Spray w/ carr
NVCR · 2026-02-12
Approved: Optune Pax
MRK · 2026-02-11
Approved: KEYTRUDA and KEYTRUDA QLEX
GILD · 2026-02-06
Approved: YESCARTA - Axicabtagene cilole
VERA · 2026-07-07 ✓
Approved: Trutakna (atacicept)
AZN · 2026-06-30 ✓
Approved: Truqap (capivasertib) + abiraterone approved
VRDN · 2026-06-30 ✓
Approved: Lumvoa (veligrotug-vvze) approved for thyroi
ARQT · 2026-06-29 ✓
Approved: ZORYVE (roflumilast) cream 0.3% approved for
GSK · 2026-06-18 ✓
Approved: Utebzi (tebipenem pivoxil) approved
SPRO · 2026-06-18 ✓
Approved: Utebzi (tebipenem pivoxil) approved
2025 · 221

Companies on this page

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