Establishment Labs (ESTA) FDA Approvals $58.45 -3.18 (-5.16%) Closing price 10/13/2026 04:00 PM EasternExtended Trading$58.42 -0.03 (-0.04%) As of 10/13/2026 07:30 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 Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsInsider TradesNews and TrendsOptions ChainOwnershipSEC FilingsShort Interest Establishment Labs' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Establishment Labs (ESTA). Over the past two years, Establishment Labs has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Motiva. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Motiva Flora® SmoothSilk® FDA Regulatory Events Motiva Flora® SmoothSilk® is a drug developed by Establishment Labs for the following indication: Tissue Expander. 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. Approved - October 5,2026Approved Drug: Motiva Flora® SmoothSilk®Announced Date: October 5, 2026Indication: Tissue Expander.AnnouncementEstablishment Labs Holdings Inc announced that the U.S. Food and Drug Administration (FDA) has approved an expanded range of Motiva SmoothSilk® Round and Motiva SmoothSilk Ergonomix® breast implants for use in the United States.Read Announcement Establishment Labs FDA Events - Frequently Asked Questions Has Establishment Labs received FDA approval? As of now, Establishment Labs (ESTA) has not received any FDA approvals for its therapy in the last two years. What drugs has Establishment Labs submitted to the FDA? In the past two years, Establishment Labs (ESTA) has reported FDA regulatory activity for Motiva Flora® SmoothSilk®. What is the most recent FDA event for Establishment Labs? The most recent FDA-related event for Establishment Labs occurred on October 5, 2026, involving Motiva Flora® SmoothSilk®. The update was categorized as "Approved," with the company reporting: "Establishment Labs Holdings Inc announced that the U.S. Food and Drug Administration (FDA) has approved an expanded range of Motiva SmoothSilk® Round and Motiva SmoothSilk Ergonomix® breast implants for use in the United States." What conditions do Establishment Labs' current drugs treat? Currently, Establishment Labs has one therapy (Motiva Flora® SmoothSilk®) targeting the following condition: Tissue Expander.. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events AgomAb Therapeutics FDA EventsAlkermes FDA EventsBeam Therapeutics FDA EventsBiomea Fusion FDA EventsBioNTech FDA EventsEnanta Pharmaceuticals FDA EventsEntera Bio FDA EventsImmuron FDA EventsKura Oncology FDA EventsEthos Technologies Inc. Class A Common Stock FDA EventsModerna FDA EventsPhio Pharmaceuticals FDA EventsPrelude Therapeutics FDA EventsRhythm Pharmaceuticals FDA EventsSAB Biotherapeutics FDA Events 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 MiniMed Group FDA Events Teleflex FDA Events Haemonetics FDA Events Pulse Biosciences FDA Events TransMedics Group FDA Events AxoGen FDA Events NovoCure FDA Events Alpha Tau Medical FDA Events Artivion FDA Events PROCEPT BioRobotics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:ESTA last updated on 10/5/2026 by MarketBeat.com Staff. 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Approved - October 5,2026Approved Drug: Motiva Flora® SmoothSilk®Announced Date: October 5, 2026Indication: Tissue Expander.AnnouncementEstablishment Labs Holdings Inc announced that the U.S. Food and Drug Administration (FDA) has approved an expanded range of Motiva SmoothSilk® Round and Motiva SmoothSilk Ergonomix® breast implants for use in the United States.Read Announcement
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