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Amgen (AMGN) FDA Events

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FDA Events for Amgen (AMGN)

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 BLINCYTO, IMDELLTRATM, LUMAKRAS®, Otezla, Tarlatamab, tezepelumab-ekko, and TEZSPIRE. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Amgen's Drugs in FDA Review

BLINCYTO (Blinatumomab) - FDA Regulatory Timeline and 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 approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

IMDELLTRATM - FDA Regulatory Timeline and Events

IMDELLTRATM is a drug developed by Amgen for the following indication: In Small Cell Lung 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.

LUMAKRAS® (SOTORASIB) - FDA Regulatory Timeline and 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.

Otezla (Apremilast) - FDA Regulatory Timeline and Events

Otezla (Apremilast) is a drug developed by Amgen for the following indication: Mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy. 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.

Tarlatamab - FDA Regulatory Timeline and Events

Tarlatamab is a drug developed by Amgen for the following indication: Small cell lung cancer (SCLC). 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 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.

TEZSPIRE - FDA Regulatory Timeline and 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.

Amgen FDA Events - Frequently Asked Questions

Yes, Amgen (AMGN) has received FDA approval for multiple therapies, including LUMAKRAS® (SOTORASIB), BLINCYTO (Blinatumomab) and Tarlatamab. This page tracks recent and historical FDA regulatory events related to Amgen's drug portfolio.

In the past two years, Amgen (AMGN) has reported FDA regulatory activity for the following drugs: TEZSPIRE, LUMAKRAS® (SOTORASIB), BLINCYTO (Blinatumomab), tezepelumab-ekko, IMDELLTRATM, Otezla (Apremilast) and Tarlatamab.

The most recent FDA-related event for Amgen occurred on March 1, 2025, involving tezepelumab-ekko. The update was categorized as "Positive Results," with the company reporting: "AstraZeneca and Amgen' announced positive results"

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

  • in chronic obstructive pulmonary disease - TEZSPIRE
  • For adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC) - LUMAKRAS® (SOTORASIB)
  • Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (ALL) - BLINCYTO (Blinatumomab)
  • For nasal polyp severity - tezepelumab-ekko
  • In Small Cell Lung Cancer - IMDELLTRATM
  • Mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy - Otezla (Apremilast)
  • Small cell lung cancer (SCLC) - Tarlatamab

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:AMGN) was last updated on 7/10/2025 by MarketBeat.com Staff
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