- A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.
The FDA regulated HEPZATO KIT, a drug associated with Delcath Systems, Inc.
5 reports, 2 independent
Updated Sep 11
Gone quiet
- Reports
- 5
- Developments
- 1
- Repetition
- 80%
New informationRepeats or wire copies
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What happened
The FDA regulated HEPZATO KIT, a drug associated with Delcath Systems, Inc.
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
-
Delcath Systems, Inc.
Nothing else this week.
Related events
- A study author is based in Johns Hopkins School of Medicine, and the research is connected to Baltimore, now involving the FDA for drug approval.
- FDA and Pfizer are seeking regulatory approval for their products.
- Unregulated products are bypassing official government approval processes.
- BioXcel Therapeutics received FDA approval for its drug and announced results from New Haven.
- Charlie's Holdings, Inc. has begun the process of seeking favorable regulatory status for its products with the FDA and has launched them across the state of California.
Coverage
Newest first; wire copies grouped- insidermonkey.com
- Business WireDelcath Systems to Participate in Upcoming Investor Conferences QUEENSBURY, N.Y., August 21, 2025--(BUSINESS WIRE)--Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on
- Business WireDelcath Systems to Participate at the Canaccord Genuity 45th Annual Growth Conference QUEENSBURY, N.Y., July 29, 2025--(BUSINESS WIRE)--Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncolog
- Business WireDelcath Systems to Host Second Quarter 2025 Earnings Call QUEENSBURY, N.Y., July 23, 2025--(BUSINESS WIRE)--Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the tre