ABVC BioPharma (ABVC) FDA Approvals $2.85 +0.08 (+2.89%) Closing price 09/12/2025 04:00 PM EasternExtended Trading$2.85 0.00 (0.00%) As of 09/12/2025 06:37 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Add Compare Share Share FDA Events Stock AnalysisChartCompetitorsEarningsFDA EventsHeadlinesOwnershipSEC FilingsShort InterestTrendsBuy This Stock ABVC BioPharma's Drug in the FDA Approval ProcessThis 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 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. Provided Update - May 9,2025Provided Update Drug: ABV-1504Announced Date: May 9, 2025Indication: For Its Natural MDD TreatmentAnnouncementABVC 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 Has ABVC BioPharma received FDA approval? As of now, ABVC BioPharma (ABVC) has not received any FDA approvals for its therapy in the last two years. What drugs has ABVC BioPharma submitted to the FDA? In the past two years, ABVC BioPharma (ABVC) has reported FDA regulatory activity for ABV-1504. What is the most recent FDA event for ABVC BioPharma? 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." What conditions do ABVC BioPharma's current drugs treat? 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 Related Companies Jade Biosciences FDA Events Allogene Therapeutics FDA Events Adherex Technologies FDA Events enGene FDA Events Tonix Pharmaceuticals FDA Events ProQR Therapeutics FDA Events Prima BioMed FDA Events Humacyte FDA Events Annexon FDA Events Editas Medicine FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA Events Tools Recent FDA Drug Approval Process Events This page (NASDAQ:ABVC) was last updated on 9/13/2025 by MarketBeat.com Staff From Our PartnersHe Called Nvidia at $1.10. 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Provided Update - May 9,2025Provided Update Drug: ABV-1504Announced Date: May 9, 2025Indication: For Its Natural MDD TreatmentAnnouncementABVC 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
