Astrazeneca

50 products tracked · names used in filings: Astrazeneca, AstraZeneca, AstraZeneca AB, Astrazeneca Ab

Upcoming milestones

Mon 18 Jan 2027🇪🇺 Expected EC decisionestimatein 65 days

Baxfendy (baxdrostat): expected EC decision

Estimated as CHMP opinion (2026-11-12) + 67 days, the standard Commission decision period. Not an official date. · AstraZeneca AB · source

Recent milestones

Thu 12 Nov 2026🇪🇺 CHMP positive opinion

Baxfendy (baxdrostat): CHMP positive opinion

AstraZeneca AB · source

Thu 08 Oct 2026🇺🇸 FDA approval

FDA approves Breztri Aerosphere (budesonide, formoterol fumarate, glycopyrrolate): new formulation or manufacturer

Astrazeneca Ab; NDA220290; New formulation or manufacturer; aerosol, metered · source

Fri 04 Sep 2026🇺🇸 FDA approval

FDA approves Etcamah (camizestrant), a new medicine

Astrazeneca; NDA220359; New molecular entity; tablet · source

Mon 20 Jul 2026🇪🇺 EU approval (EC decision)

Etcamah (camizestrant) approved in the EU

Marketing authorisation to AstraZeneca AB; Additional monitoring · source

Thu 21 May 2026🇪🇺 CHMP positive opinion

Etcamah (camizestrant): CHMP positive opinion

AstraZeneca AB; Additional monitoring · source

Fri 15 May 2026🇺🇸 FDA approval

FDA approves Baxfendy (baxdrostat), a new medicine

Astrazeneca Ab; NDA219878; New molecular entity, Priority review; tablet · source

Fri 24 Apr 2026🇺🇸 FDA approval

FDA approves Saphnelo (anifrolumab-fnia), a new medicine

Astrazeneca Ab; BLA761451; New biologic; injection, vial · source

Products

ProductStatusApproved
🇪🇺Zemfirza
cediranib maleate
Application withdrawn
🇪🇺Ximelagatran 36 mg film coated tablets
ximelagatran
Application withdrawn
🇪🇺Zactima
vandetanib
Application withdrawn
🇪🇺Baxfendy
baxdrostat
Opinion
🇺🇸Breztri Aerosphere
budesonide, formoterol fumarate, glycopyrrolate
Approved2026-10-08
🇺🇸Etcamah
camizestrant
Approved2026-09-04
🇪🇺Etcamah
camizestrant
Authorised2026-07-20
🇺🇸Baxfendy
baxdrostat
Approved2026-05-15
🇺🇸Saphnelo
anifrolumab-fnia
Approved2026-04-24
🇪🇺Wainzua
eplontersen
Authorised2025-03-06
🇪🇺Kavigale
sipavibart
Authorised2025-01-20
🇪🇺Truqap
capivasertib
Authorised2024-06-17
🇪🇺Fluenz
influenza vaccine (live attenuated, nasal)
Authorised2024-06-03
🇪🇺Imjudo
tremelimumab
Authorised2023-02-20
🇪🇺Tremelimumab AstraZeneca
tremelimumab
Withdrawn2023-02-20
🇪🇺Tezspire
tezepelumab
Authorised2022-09-19
🇪🇺Evusheld
tixagevimab;cilgavimab
Withdrawn2022-03-25
🇪🇺Saphnelo
anifrolumab
Authorised2022-02-14
🇪🇺Riltrava Aerosphere
formoterol fumarate dihydrate;glycopyrronium;budesonide
Authorised2022-01-06
🇪🇺Koselugo
selumetinib
Authorised2021-06-17
🇪🇺Lumoxiti
moxetumomab pasudotox
Withdrawn2021-02-08
🇪🇺Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
COVID-19 Vaccine (ChAdOx1-S [recombinant])
Withdrawn2021-01-29
🇪🇺Trixeo Aerosphere
formoterol;glycopyrronium bromide;budesonide
Authorised2020-12-09
🇪🇺Calquence
acalabrutinib
Authorised2020-11-05
🇪🇺Qtrilmet
metformin hydrochloride;saxagliptin;dapagliflozin
Withdrawn2019-11-11
🇪🇺Ondexxya
andexanet alfa
Authorised2019-04-26
🇪🇺Bevespi Aerosphere
glycopyrronium;formoterol fumarate dihydrate
Authorised2018-12-18
🇪🇺Imfinzi
durvalumab
Authorised2018-09-21
🇪🇺Lokelma
sodium zirconium cyclosilicate
Authorised2018-03-22
🇪🇺Fasenra
benralizumab
Authorised2018-01-08
🇪🇺Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune)
pandemic influenza vaccine (H5N1) (live attenuated, nasal)
Authorised2016-05-20
🇪🇺Tagrisso
osimertinib
Authorised2016-02-01
🇪🇺Ebymect
dapagliflozin;metformin
Authorised2015-11-15
🇪🇺Edistride
dapagliflozin
Authorised2015-11-09
🇪🇺Lynparza
olaparib
Authorised2014-12-16
🇪🇺Xigduo
dapagliflozin;metformin
Authorised2014-01-16
🇪🇺Fluenz Tetra
influenza vaccine (live attenuated, nasal)
Withdrawn2013-12-04
🇪🇺Forxiga
dapagliflozin
Authorised2012-11-11
🇪🇺Komboglyze
saxagliptin;metformin hydrochloride
Authorised2011-11-24
🇪🇺Bydureon
exenatide
Withdrawn2011-06-17
🇪🇺Libertek
roflumilast
Withdrawn2011-02-28
🇪🇺Daliresp
roflumilast
Withdrawn2011-02-28
🇪🇺Brilique
ticagrelor
Authorised2010-12-03
🇪🇺Possia
ticagrelor
Withdrawn2010-12-03
🇪🇺Daxas
roflumilast
Authorised2010-07-05
🇪🇺Onglyza
saxagliptin
Authorised2009-09-30
🇪🇺Iressa
gefitinib
Authorised2009-06-24
🇪🇺Byetta
exenatide
Withdrawn2006-11-20
🇪🇺Faslodex
fulvestrant
Authorised2004-03-09
🇪🇺Synagis
palivizumab
Authorised1999-08-13

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.