FDA Events for ABVC BioPharma (ABVC)
This section highlights FDA-related milestones and regulatory updates for drugs developed by ABVC BioPharma (ABVC).
Over the past two years, ABVC BioPharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ABV-1504. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ABV-1504 - FDA Regulatory Timeline and Events
ABV-1504 is a drug developed by ABVC BioPharma for the following indication: For Its Natural MDD Treatment.
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:
- ABV-1504
- Announced Date:
- May 9, 2025
- Indication:
- For Its Natural MDD Treatment
Announcement
ABVC BioPharma, Inc announced that the Japan Patent Office has granted a new patent protection for its Major Depressive Disorder (MDD) candidate, ABV-1504.
Read Announcement
ABVC BioPharma FDA Events - Frequently Asked Questions
As of now, ABVC BioPharma (ABVC) has not received any FDA approvals for its therapy in the last two years.
In the past two years, ABVC BioPharma (ABVC) has reported FDA regulatory activity for ABV-1504.
The most recent FDA-related event for ABVC BioPharma occurred on May 9, 2025, involving ABV-1504. The update was categorized as "Provided Update," with the company reporting: "ABVC BioPharma, Inc announced that the Japan Patent Office has granted a new patent protection for its Major Depressive Disorder (MDD) candidate, ABV-1504."
Currently, ABVC BioPharma has one therapy (ABV-1504) targeting the following condition: For Its Natural MDD Treatment.
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:ABVC) was last updated on 7/10/2025 by MarketBeat.com Staff
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