FDA Events for MorphoSys (MOR)
This section highlights FDA-related milestones and regulatory updates for drugs developed by MorphoSys (MOR).
Over the past two years, MorphoSys has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Tafasitamab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Tafasitamab + (Lenalidomide and Rituximab) - FDA Regulatory Timeline and Events
Tafasitamab + (Lenalidomide and Rituximab) is a drug developed by MorphoSys for the following indication: Relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL).
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:
- Tafasitamab + (Lenalidomide and Rituximab)
- Announced Date:
- November 25, 2024
- Indication:
- Relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL)
Announcement
Incyte announced that the Company will present new data from across its oncology portfolio at the 2024 American Society of Hematology (ASH) Annual Meeting in San Diego.
AI Summary
Incyte announced that it will present new oncology data at the 2024 American Society of Hematology (ASH) Annual Meeting in San Diego. The company’s portfolio will be highlighted through twenty presentations, which include late-breaking, oral, and poster sessions, covering data from several of its medicines. A key highlight is the late-breaking oral presentation on tafasitamab from the Phase 3 inMIND study. This study focuses on tafasitamab’s use in relapsed or refractory follicular lymphoma, offering promising insight into treatment options for patients with limited alternatives.
These presentations underscore Incyte’s commitment to advancing cancer treatment through rigorous clinical research. The data will be shared during dedicated sessions at the conference and discussed further during a virtual analyst and investor event on December 12, 2024. This approach reinforces the company’s innovative strategies in oncology care.
Read Announcement
MorphoSys FDA Events - Frequently Asked Questions
As of now, MorphoSys (MOR) has not received any FDA approvals for its therapy in the last two years.
In the past two years, MorphoSys (MOR) has reported FDA regulatory activity for Tafasitamab + (Lenalidomide and Rituximab).
The most recent FDA-related event for MorphoSys occurred on November 25, 2024, involving Tafasitamab + (Lenalidomide and Rituximab). The update was categorized as "New Data," with the company reporting: "Incyte announced that the Company will present new data from across its oncology portfolio at the 2024 American Society of Hematology (ASH) Annual Meeting in San Diego."
Currently, MorphoSys has one therapy (Tafasitamab + (Lenalidomide and Rituximab)) targeting the following condition: Relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL).
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- 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:MOR) was last updated on 7/13/2025 by MarketBeat.com Staff
