FDA Events for Kamada (KMDA)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Kamada (KMDA).
Over the past two years, Kamada has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CYTOGAM. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CYTOGAM - FDA Regulatory Timeline and Events
CYTOGAM is a drug developed by Kamada for the following indication: Cytomegalovirus Immune Globulin Intravenous [Human]) (CMV-IGIV).
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:
- CYTOGAM
- Announced Date:
- May 5, 2025
- Indication:
- Cytomegalovirus Immune Globulin Intravenous [Human]) (CMV-IGIV)
Announcement
Kamada Ltd. announced the launch of a new post-marketing research program aimed at generating key data in support of the benefits of CYTOGAM®, the Company's Cytomegalovirus Immune Globulin, in the management of cytomegalovirus (CMV) in solid organ transplantation.
AI Summary
Kamada Ltd. has launched a new post-marketing research program to gather important data on CYTOGAM®, its Cytomegalovirus Immune Globulin product, for managing CMV in solid organ transplant patients. The program will conduct 10 studies in collaboration with top U.S. physicians, mainly through investigator-initiated research, to explore how CYTOGAM can prevent late-onset CMV and reduce active disease. Researchers will also examine different dosing strategies, study the mechanism of action of CYTOGAM against CMV and other viruses, and assess the economic impact of CMV in transplant patients. Additionally, a clinical practice study will look into current methods of CMV management in lung transplantation. The data, expected to be shared in professional journals and medical meetings, may demonstrate new benefits of CYTOGAM that could support wider use of this treatment in the coming years.
Read Announcement
Kamada FDA Events - Frequently Asked Questions
As of now, Kamada (KMDA) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Kamada (KMDA) has reported FDA regulatory activity for CYTOGAM.
The most recent FDA-related event for Kamada occurred on May 5, 2025, involving CYTOGAM. The update was categorized as "Provided Update," with the company reporting: "Kamada Ltd. announced the launch of a new post-marketing research program aimed at generating key data in support of the benefits of CYTOGAM®, the Company's Cytomegalovirus Immune Globulin, in the management of cytomegalovirus (CMV) in solid organ transplantation."
Currently, Kamada has one therapy (CYTOGAM) targeting the following condition: Cytomegalovirus Immune Globulin Intravenous [Human]) (CMV-IGIV).
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:KMDA) was last updated on 7/12/2025 by MarketBeat.com Staff
