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Halozyme Therapeutics (HALO) FDA Events

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FDA Events for Halozyme Therapeutics (HALO)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Halozyme Therapeutics (HALO). Over the past two years, Halozyme Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as DARZALEX, DARZALEX, and Tecentriq. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Halozyme Therapeutics' Drugs in FDA Review

DARZALEX (daratumumab) - FDA Regulatory Timeline and Events

DARZALEX (daratumumab) is a drug developed by Halozyme Therapeutics for the following indication: Newly diagnosed systemic light chain (AL) amyloidosis. 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.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone - FDA Regulatory Timeline and Events

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone is a drug developed by Halozyme Therapeutics for the following indication: Multiple Myeloma After First / Subsequent Relapse. 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.

Tecentriq Hybreza - FDA Regulatory Timeline and Events

Tecentriq Hybreza is a drug developed by Halozyme Therapeutics for the following indication: For Multiple Types of 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.

Halozyme Therapeutics FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Halozyme Therapeutics (HALO) has reported FDA regulatory activity for the following drugs: DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone, DARZALEX (daratumumab) and Tecentriq Hybreza.

The most recent FDA-related event for Halozyme Therapeutics occurred on June 3, 2025, involving DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone. The update was categorized as "Data," with the company reporting: "Johnson & Johnson announced data from two studies highlighting that a DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet regimen demonstrated deep and sustained minimal residual disease (MRD) negativity rates, and improved long-term progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM), regardless of transplant status.1,2,3 Findings were highlighted as oral presentations of an analysis of sustained MRD in transplant-eligible patients from the Phase 3 PERSEUS study (Abstract #7501) and a subgroup analysis of transplant-ineligible patients in the Phase 3 CEPHEUS study (Abstract #7516) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting."

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

  • Multiple Myeloma After First / Subsequent Relapse - DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone
  • Newly diagnosed systemic light chain (AL) amyloidosis - DARZALEX (daratumumab)
  • For Multiple Types of Cancer - Tecentriq Hybreza

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