This section highlights FDA-related milestones and regulatory updates for drugs developed by Amgen (AMGN).
Over the past two years, Amgen has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TEZSPIRE, Tarlatamab, tezepelumab-ekko, Repatha, LUMAKRAS®, and BLINCYTO. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
TEZSPIRE FDA Regulatory Events
TEZSPIRE is a drug developed by Amgen for the following indication: in chronic obstructive pulmonary disease.
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.
- Drug:
- TEZSPIRE
- Announced Date:
- October 20, 2026
- Indication:
- in chronic obstructive pulmonary disease
Announcement
AstraZeneca announced Full results from the positive Phase III CROSSING trial showed that AstraZeneca and Amgen’s TEZSPIRE® (tezepelumab) demonstrated statistically significant and clinically meaningful improvements in the co-primary endpoints of histologic remission and the frequency and severity of dysphagia (difficulty swallowing) in adolescent and adult patients with symptomatic and uncontrolled eosinophilic esophagitis (EoE), despite continued treatment with background medications.
Read Announcement- Drug:
- TEZSPIRE
- Announced Date:
- August 27, 2026
- Indication:
- in chronic obstructive pulmonary disease
Announcement
Amgen announced positive top-line results from the Phase 3 CROSSING trial of TEZSPIRE® (tezepelumab-ekko) in patients living with eosinophilic esophagitis (EoE).
Read Announcement
Tarlatamab FDA Regulatory Events
Tarlatamab is a drug developed by Amgen for the following indication: Small cell lung cancer (SCLC).
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.
- Drug:
- Tarlatamab
- Announced Date:
- November 20, 2025
- Indication:
- Small cell lung cancer (SCLC)
Announcement
Amgen announced today that the U.S. Food and Drug Administration (FDA) has granted full approval to IMDELLTRA® (tarlatamab-dlle) for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
AI Summary
Amgen announced that the U.S. Food and Drug Administration has granted full approval to IMDELLTRA® (tarlatamab-dlle) for adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease progressed on or after platinum-based chemotherapy. The approval is based on results from the global Phase 3 DeLLphi-304 study.
DeLLphi-304 showed IMDELLTRA reduced the risk of death by 40% versus standard-of-care chemotherapy and extended median overall survival by more than five months (median OS 13.6 vs. 8.3 months; hazard ratio 0.60; 95% CI 0.47–0.77; P < 0.001). These findings represent a statistically significant survival benefit in the second-line setting for ES-SCLC.
Safety in DeLLphi-304 was consistent with prior experience: fewer Grade 3 or greater adverse events with IMDELLTRA (54% vs. 80% for chemotherapy). Cytokine release syndrome was mostly low grade and manageable. The National Comprehensive Cancer Network updated guidelines to list tarlatamab as a Category 1 preferred option for this patient group.
Read Announcement
Tezepelumab-ekko FDA Regulatory Events
Tezepelumab-ekko is a drug developed by Amgen 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.
- Drug:
- tezepelumab-ekko
- Announced Date:
- October 17, 2025
- Indication:
- For nasal polyp severity
Announcement
Amgen and AstraZeneca announced that the U.S. Food and Drug Administration (FDA) approved TEZSPIRE® (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients aged 12 years and older.
AI Summary
Amgen and AstraZeneca announced that the U.S. Food and Drug Administration approved TEZSPIRE® (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients aged 12 years and older. TEZSPIRE is the first biologic targeting thymic stromal lymphopoietin (TSLP) for this disease.
CRSwNP affects about 320 million people worldwide, causing chronic inflammation, nasal blockage, and loss of smell. In the Phase III WAYPOINT trial, TEZSPIRE led to significant reductions in polyp size, nearly eliminated the need for surgery, and cut systemic corticosteroid use compared to placebo.
This approval gives patients a new treatment option that addresses the underlying inflammation driving CRSwNP. TEZSPIRE’s safety profile was consistent with earlier studies; the most common side effects were nasopharyngitis, upper respiratory tract infections, and mild injection-site reactions.
Read Announcement- Drug:
- tezepelumab-ekko
- Announced Date:
- March 1, 2025
- Indication:
- For nasal polyp severity
Announcement
AstraZeneca and Amgen' announced positive results
AI Summary
AstraZeneca and Amgen have announced positive Phase III WAYPOINT trial results for TEZSPIRE® (tezepelumab-ekko) in patients with chronic rhinosinusitis with nasal polyps. The trial showed that TEZSPIRE significantly reduced nasal polyp size, eased nasal congestion, and lessened the need for surgery compared to placebo. Improvements were observed as early as week two and maintained through week 52, with dramatic decreases in systemic corticosteroid use.
Notably, TEZSPIRE nearly eliminated the need for subsequent nasal polyp surgery, reducing surgery rates by 98%, while corticosteroid use dropped by 88%. This partnership highlights TEZSPIRE’s promise as a less invasive treatment that can improve the quality of life for patients with CRSwNP by reducing chronic symptoms and surgical intervention needs.
Read Announcement
Repatha (Evolocumab) FDA Regulatory Events
Repatha (Evolocumab) is a drug developed by Amgen for the following indication: HIV who have high cholesterol, as well as new data from FOURIER evaluating biomarkers of major cardiovascular (CV) events.
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.
- Drug:
- Repatha (Evolocumab)
- Announced Date:
- October 2, 2025
- Indication:
- HIV who have high cholesterol, as well as new data from FOURIER evaluating biomarkers of major cardiovascular (CV) events
Announcement
Amgen announced the Phase 3 VESALIUS-CV clinical trial met its dual primary endpoints demonstrating that Repatha® (evolocumab) significantly reduced the risk of major adverse cardiovascular events (MACE) in individuals without a prior history of heart attack or stroke.
AI Summary
Amgen announced that its Phase 3 VESALIUS-CV clinical trial met both dual primary endpoints by showing that Repatha® (evolocumab) significantly reduced the risk of major adverse cardiovascular events (MACE) in individuals without a prior heart attack or stroke. The study enrolled over 12,000 high-risk patients, about 85% of whom were already on high-intensity or moderate LDL-C lowering therapy such as statins, and followed them for a median of approximately 4.5 years.
VESALIUS-CV evaluated two composite endpoints: the first included coronary heart disease death, heart attack, or ischemic stroke; the second added any ischemia-driven arterial revascularization. Both endpoints showed statistically and clinically significant reductions in events, and no new safety signals emerged. These results establish Repatha as the first PCSK9 inhibitor to demonstrate a meaningful decrease in cardiovascular events when used for primary prevention in high-risk adults without prior heart attack or stroke.
Read Announcement- Drug:
- Repatha (Evolocumab)
- Announced Date:
- August 25, 2025
- Indication:
- HIV who have high cholesterol, as well as new data from FOURIER evaluating biomarkers of major cardiovascular (CV) events
Announcement
Amgen announced that the U.S. Food and Drug Administration (FDA) has broadened the approved use of Repatha® (evolocumab) to include adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C), commonly known as 'bad cholesterol.'
AI Summary
Amgen announced that the U.S. Food and Drug Administration (FDA) has broadened the approved use of Repatha® (evolocumab) to include adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C), commonly known as “bad cholesterol.” The update removes a prior requirement for patients to have diagnosed cardiovascular disease and aims to help more people lower their LDL-C and reduce the chance of a heart attack or stroke.
Murdo Gordon said many at-risk adults still do not reach LDL-C goals with statins and need more treatment options. Repatha significantly lowers LDL-C, especially for those uncontrolled with statins or intolerant to them. The FDA also expanded Repatha monotherapy for patients with homozygous familial hypercholesterolemia (HoFH) and stressed that it be used alongside diet and exercise. Repatha blocks PCSK9, letting the liver clear more LDL-C from the blood.
Read Announcement
LUMAKRAS® (SOTORASIB) FDA Regulatory Events
LUMAKRAS® (SOTORASIB) is a drug developed by Amgen for the following indication: For adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC).
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LUMAKRAS® (SOTORASIB)
- Announced Date:
- January 17, 2025
- Indication:
- For adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC)
Announcement
Amgen announced that the U.S. Food and Drug Administration (FDA) has approved LUMAKRAS® (sotorasib) in combination with Vectibix® (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
AI Summary
Amgen announced that the U.S. FDA has approved LUMAKRAS® (sotorasib) in combination with Vectibix® (panitumumab) for adult patients with KRAS G12C-mutated metastatic colorectal cancer. This approval applies to patients who have already received chemotherapy treatments based on fluoropyrimidine, oxaliplatin, and irinotecan, and whose mutation has been confirmed by an FDA-approved test. The decision comes after promising results from the pivotal Phase 3 CodeBreaK 300 study. This study demonstrated that the combination treatment doubled progression-free survival compared to the standard care. As the first targeted therapy duo specifically addressing KRAS G12C-mutated mCRC in the chemorefractory setting, this new treatment option offers hope for improved management of a challenging and aggressive form of cancer, paving the way for future advancements in precision medicine for colorectal cancer patients.
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BLINCYTO (Blinatumomab) FDA Regulatory Events
BLINCYTO (Blinatumomab) is a drug developed by Amgen for the following indication: Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (ALL).
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.
- Drug:
- BLINCYTO (Blinatumomab)
- Announced Date:
- December 7, 2024
- Indication:
- Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (ALL)
Announcement
Amgen announced new data demonstrating that adding BLINCYTO® (blinatumomab) to chemotherapy significantly improves disease-free survival (DFS) in newly diagnosed pediatric patients with National Cancer Institute (NCI) standard risk (SR) B-cell acute lymphoblastic leukemia (B-ALL) of average or higher risk of relapse.
AI Summary
Amgen recently announced breakthrough Phase 3 study data showing that adding BLINCYTO® (blinatumomab) to chemotherapy improves outcomes in newly diagnosed pediatric patients with National Cancer Institute standard risk B-cell acute lymphoblastic leukemia (B-ALL) who are at average or higher risk of relapse. The study, conducted by the Children’s Oncology Group, found that patients receiving the combination therapy achieved a three-year disease-free survival (DFS) rate of 96%, compared to 87.9% for those treated with chemotherapy alone. This significant improvement represents a 61% reduction in the risk of disease relapse, secondary malignant neoplasms, or remission death. The encouraging results support BLINCYTO® as a critical addition to current treatment strategies, potentially offering similar positive outcomes in standard risk patients as seen in those with more favorable profiles.
Read Announcement
