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CASI Pharmaceuticals (CASI) FDA Events

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FDA Events for CASI Pharmaceuticals (CASI)

This section highlights FDA-related milestones and regulatory updates for drugs developed by CASI Pharmaceuticals (CASI). Over the past two years, CASI Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as CID-103. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

CID-103 - FDA Regulatory Timeline and Events

CID-103 is a drug developed by CASI Pharmaceuticals for the following indication: Relapsed Or Refractory Multiple Myeloma. 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.

CASI Pharmaceuticals FDA Events - Frequently Asked Questions

As of now, CASI Pharmaceuticals (CASI) has not received any FDA approvals for its therapy in the last two years.

In the past two years, CASI Pharmaceuticals (CASI) has reported FDA regulatory activity for CID-103.

The most recent FDA-related event for CASI Pharmaceuticals occurred on January 6, 2025, involving CID-103. The update was categorized as "Dosing Update," with the company reporting: "CASI Pharmaceuticals, Inc. announced that the first patient has been dosed in the Phase 1/2 trial to evaluate the safety and tolerability of CID-103 in adult patients with chronic Immune Thrombocytopenia (ITP) in China."

Currently, CASI Pharmaceuticals has one therapy (CID-103) targeting the following condition: Relapsed Or Refractory Multiple Myeloma.

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:CASI) was last updated on 7/11/2025 by MarketBeat.com Staff
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