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AstraZeneca (AZN) FDA Events

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FDA Events for AstraZeneca (AZN)

This section highlights FDA-related milestones and regulatory updates for drugs developed by AstraZeneca (AZN). Over the past two years, AstraZeneca has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as AIRSUPRA, AZP-3601, BREZTRI, CALQUENCE, capivasertib, casdatifan, and C-CAR031. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

AstraZeneca's Drugs in FDA Review

AIRSUPRA - FDA Regulatory Timeline and Events

AIRSUPRA is a drug developed by AstraZeneca for the following indication: For asthma. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

AZP-3601 - FDA Regulatory Timeline and Events

AZP-3601 is a drug developed by AstraZeneca for the following indication: For the treatment of chronic hypoparathyroidism (HypoPT). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

BREZTRI AEROSPHERE - FDA Regulatory Timeline and Events

BREZTRI AEROSPHERE is a drug developed by AstraZeneca for the following indication: To improve cardiopulmonary outcomes in people with COPD. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

CALQUENCE - FDA Regulatory Timeline and Events

CALQUENCE is a drug developed by AstraZeneca for the following indication: In patients with treatment-naïve CLL.1. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

capivasertib - FDA Regulatory Timeline and Events

capivasertib is a drug developed by AstraZeneca for the following indication: In patients with locally advanced (inoperable) or metastatic triple-negative breast cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

casdatifan - FDA Regulatory Timeline and Events

casdatifan is a drug developed by AstraZeneca for the following indication: In patients with ccRCC. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

C-CAR031 - FDA Regulatory Timeline and Events

C-CAR031 is a drug developed by AstraZeneca for the following indication: in patients with liver cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Datopotamab deruxtecan (Dato-DXd) - FDA Regulatory Timeline and Events

Datopotamab deruxtecan (Dato-DXd) is a drug developed by AstraZeneca for the following indication: Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

datopotamab deruxtecan-dlnk - FDA Regulatory Timeline and Events

datopotamab deruxtecan-dlnk is a drug developed by AstraZeneca for the following indication: For patients with previously treated metastatic HR-positive, HER2-negative breast cancer. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Durvalumab - FDA Regulatory Timeline and Events

Durvalumab is a drug developed by AstraZeneca for the following indication: Treatment Of Locally Advanced Or Metastatic Biliary Tract Cancer In Combination With Chemotherapy. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Enhertu (Trastuzumab deruxtecan) - FDA Regulatory Timeline and Events

Enhertu (Trastuzumab deruxtecan) is a drug developed by AstraZeneca for the following indication: Untreated HER2 Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

ENHERTU® (fam-trastuzumab deruxtecan-nxki) - FDA Regulatory Timeline and Events

ENHERTU® (fam-trastuzumab deruxtecan-nxki) is a drug developed by AstraZeneca for the following indication: For the treatment of adult patients with unresectable or metastatic HER2 positive. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

FARXIGA (dapagliflozin) - FDA Regulatory Timeline and Events

FARXIGA (dapagliflozin) is a drug developed by AstraZeneca for the following indication: chronic kidney disease (CKD) in adults with and without type 2 diabetes (T2D). This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

FASENRA - FDA Regulatory Timeline and Events

FASENRA is a drug developed by AstraZeneca for the following indication: For treatment of children aged 6 to 11 with severe asthma. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Imfinzi + tremelimumab (HIMALAYA) - FDA Regulatory Timeline and Events

Imfinzi + tremelimumab (HIMALAYA) is a drug developed by AstraZeneca for the following indication: First line Hepatocellular carcinoma (HCC). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

LYNPARZA (Olaparib) - FDA Regulatory Timeline and Events

LYNPARZA (Olaparib) is a drug developed by AstraZeneca for the following indication: BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

POTOMAC - FDA Regulatory Timeline and Events

POTOMAC is a drug developed by AstraZeneca for the following indication: for high-risk non-muscle-invasive bladder cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

SAPHNELO (anifrolumab) - FDA Regulatory Timeline and Events

SAPHNELO (anifrolumab) is a drug developed by AstraZeneca for the following indication: Moderate to Severe Systemic Lupus Erythematosus BW. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

SERENA-6 - FDA Regulatory Timeline and Events

SERENA-6 is a drug developed by AstraZeneca for the following indication: For HR-Positive Breast Cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

sipavibart - FDA Regulatory Timeline and Events

sipavibart is a drug developed by AstraZeneca for the following indication: for COVID-19 prevention. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

TAGRISSO® (osimertinib) - FDA Regulatory Timeline and Events

TAGRISSO® (osimertinib) is a drug developed by AstraZeneca for the following indication: Third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

tezepelumab-ekko - FDA Regulatory Timeline and Events

tezepelumab-ekko is a drug developed by AstraZeneca for the following indication: For nasal polyp severity. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

VOYDEYA - FDA Regulatory Timeline and Events

VOYDEYA is a drug developed by AstraZeneca for the following indication: For treatment of extravascular hemolysis in adults with the rare disease PNH. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

AstraZeneca FDA Events - Frequently Asked Questions

Yes, AstraZeneca (AZN) has received FDA approval for multiple therapies, including datopotamab deruxtecan-dlnk, TAGRISSO® (osimertinib), FASENRA and FARXIGA (dapagliflozin). This page tracks recent and historical FDA regulatory events related to AstraZeneca's drug portfolio.

In the past two years, AstraZeneca (AZN) has reported FDA regulatory activity for the following drugs: Durvalumab, TAGRISSO® (osimertinib), Enhertu (Trastuzumab deruxtecan), ENHERTU® (fam-trastuzumab deruxtecan-nxki), Datopotamab deruxtecan (Dato-DXd), CALQUENCE, SERENA-6, casdatifan, datopotamab deruxtecan-dlnk, AIRSUPRA, BREZTRI AEROSPHERE, capivasertib, FASENRA, VOYDEYA, POTOMAC, AZP-3601, tezepelumab-ekko, SAPHNELO (anifrolumab), Imfinzi + tremelimumab (HIMALAYA), LYNPARZA (Olaparib), sipavibart, FARXIGA (dapagliflozin) and C-CAR031.

The most recent FDA-related event for AstraZeneca occurred on June 30, 2025, involving TAGRISSO® (osimertinib). The update was categorized as "Approved," with the company reporting: "HUTCHMED (China) Limited announces that the New Drug Application ("NDA") for the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) has been granted approval by the China National Medical Products Administration ("NMPA") for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor ("EGFR") mutation-positive non-squamous non-small cell lung cancer ("NSCLC") with MET amplification after disease progression on EGFR tyrosine kinase inhibitor ("TKI") therapy."

Current therapies from AstraZeneca in review with the FDA target conditions such as:

  • Treatment Of Locally Advanced Or Metastatic Biliary Tract Cancer In Combination With Chemotherapy - Durvalumab
  • Third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases. - TAGRISSO® (osimertinib)
  • Untreated HER2 Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC) - Enhertu (Trastuzumab deruxtecan)
  • For the treatment of adult patients with unresectable or metastatic HER2 positive - ENHERTU® (fam-trastuzumab deruxtecan-nxki)
  • Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer - Datopotamab deruxtecan (Dato-DXd)
  • In patients with treatment-naïve CLL.1 - CALQUENCE
  • For HR-Positive Breast Cancer - SERENA-6
  • In patients with ccRCC - casdatifan
  • For patients with previously treated metastatic HR-positive, HER2-negative breast cancer - datopotamab deruxtecan-dlnk
  • For asthma - AIRSUPRA
  • To improve cardiopulmonary outcomes in people with COPD - BREZTRI AEROSPHERE
  • In patients with locally advanced (inoperable) or metastatic triple-negative breast cancer - capivasertib
  • For treatment of children aged 6 to 11 with severe asthma - FASENRA
  • For treatment of extravascular hemolysis in adults with the rare disease PNH - VOYDEYA
  • for high-risk non-muscle-invasive bladder cancer - POTOMAC
  • For the treatment of chronic hypoparathyroidism (HypoPT) - AZP-3601
  • For nasal polyp severity - tezepelumab-ekko
  • Moderate to Severe Systemic Lupus Erythematosus BW - SAPHNELO (anifrolumab)
  • First line Hepatocellular carcinoma (HCC) - Imfinzi + tremelimumab (HIMALAYA)
  • BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer - LYNPARZA (Olaparib)
  • for COVID-19 prevention - sipavibart
  • chronic kidney disease (CKD) in adults with and without type 2 diabetes (T2D) - FARXIGA (dapagliflozin)
  • in patients with liver cancer. - C-CAR031

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:AZN) was last updated on 7/10/2025 by MarketBeat.com Staff
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