- A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.
Cellectar Biosciences received Breakthrough Therapy Designation from the FDA for its drug iopofosine I 131.
3 reports, 2 independent
Updated Aug 17
Gone quiet
- Reports
- 3
- Developments
- 1
- Repetition
- 67%
New informationRepeats or wire copies
AI-generated analysis. Brind wrote this summary from the reports listed below. It can be wrong. Each section says how much you can rely on it, and the sources are linked so you can check.
What happened
Cellectar Biosciences received Breakthrough Therapy Designation from the FDA for its drug iopofosine I 131.
Who's involved
What this event is mainly aboutKeep exploring
Part of
A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.Also in this story
- A partnership with BARDA has accelerated the development of SCY-247 for the company.
- A company plans to submit regulatory applications to the FDA, EMA, and Australian TGA.
- Approval leads to procurement process initiation.
- UroGen Pharma Ltd., headquartered in Princeton, is seeking FDA approval for its products for the U.S. market.
The entities involved
- FDA
-
Cellectar Biosciences (United States)
company in Madison, United States
Nothing else this week.
Related events
- Iovance Biotherapeutics received FDA approval for its therapy, and the company is listed on Nasdaq.
- Intellia Therapeutics is seeking FDA approval for its drug Lonvo-Z.
- Data was presented in Athens supporting a future U.S. NDA submission to the FDA.
- The FDA and Intellia Therapeutics are preparing a regulatory filing for product approval.
- BridgeBio plans to submit MAA and NDA for infigratinib review to the FDA.
Coverage
Newest first; wire copies grouped- yahoo.com
- GlobeNewswireCellectar Biosciences Reports Second Quarter 2025 Financial Results and Provides a Corporate Update Intend to Pursue an NDA Submission to the U.S. FDA under Accelerated Approval Pathway for Iopofosin
- GlobeNewswireCellectar Biosciences to Report Second Quarter Financial Results and Host a Conference Call on Thursday, August 14, 2025 FLORHAM PARK, N.J., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, I