Roche (RHHBY) FDA Approvals $60.98 +1.80 (+3.04%) As of 02:14 PM Eastern Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartFDA EventsInsider TradesNews and TrendsOwnershipShort Interest Roche's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Roche (RHHBY). Over the past two years, Roche has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Gavreto. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Gavreto (Pralsetinib) FDA Regulatory Events Gavreto (Pralsetinib) is a drug developed by Roche for the following indication: Rearranged during transfection (RET) fusion-positive advanced Non-small cell lung cancer (NSCLC). 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. Analysis - October 19,2026Analysis Drug: Gavreto (Pralsetinib)Announced Date: October 19, 2026Indication: Rearranged during transfection (RET) fusion-positive advanced Non-small cell lung cancer (NSCLC)Other Companies Involved: NASDAQ:RIGL OTCMKTS:RHHVF AnnouncementRigel Pharmaceuticals, Inc. announced analysis of the pooled efficacy and safety data from two clinical trials of GAVRETO® (pralsetinib), ARROW (NCT03037385) and TAPISTRY (NCT04589845), in patients with rearranged during transfection (RET) fusion-positive solid tumors will be presented in a rapid oral session at the European Society For Medical Oncology (ESMO) Congress 2026 on Sunday, October 25, 2026.Read Announcement Roche FDA Events - Frequently Asked Questions Has Roche received FDA approval? As of now, Roche (RHHBY) has not received any FDA approvals for its therapy in the last two years. What drugs has Roche submitted to the FDA? In the past two years, Roche (RHHBY) has reported FDA regulatory activity for Gavreto (Pralsetinib). What is the most recent FDA event for Roche? The most recent FDA-related event for Roche occurred on October 19, 2026, involving Gavreto (Pralsetinib). The update was categorized as "Analysis," with the company reporting: "Rigel Pharmaceuticals, Inc. announced analysis of the pooled efficacy and safety data from two clinical trials of GAVRETO® (pralsetinib), ARROW (NCT03037385) and TAPISTRY (NCT04589845), in patients with rearranged during transfection (RET) fusion-positive solid tumors will be presented in a rapid oral session at the European Society For Medical Oncology (ESMO) Congress 2026 on Sunday, October 25, 2026." What conditions do Roche's current drugs treat? Currently, Roche has one therapy (Gavreto (Pralsetinib)) targeting the following condition: Rearranged during transfection (RET) fusion-positive advanced Non-small cell lung cancer (NSCLC). 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Common Stock FDA EventsErasca FDA EventsImmuneering FDA EventsKaryopharm Therapeutics FDA EventsKura Oncology FDA EventsLyell Immunopharma FDA EventsIntellia Therapeutics FDA EventsPMV Pharmaceuticals FDA EventsRadiopharm Theranostics FDA EventsRhythm Pharmaceuticals 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 Eli Lilly and Company FDA Events Johnson & Johnson FDA Events Merck & Co., Inc. FDA Events Novartis FDA Events AstraZeneca FDA Events Novo Nordisk A/S FDA Events Pfizer FDA Events Bristol Myers Squibb FDA Events GSK FDA Events Sanofi FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for OTCMKTS:RHHBY last updated on 10/19/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. 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Analysis - October 19,2026Analysis Drug: Gavreto (Pralsetinib)Announced Date: October 19, 2026Indication: Rearranged during transfection (RET) fusion-positive advanced Non-small cell lung cancer (NSCLC)Other Companies Involved: NASDAQ:RIGL OTCMKTS:RHHVF AnnouncementRigel Pharmaceuticals, Inc. announced analysis of the pooled efficacy and safety data from two clinical trials of GAVRETO® (pralsetinib), ARROW (NCT03037385) and TAPISTRY (NCT04589845), in patients with rearranged during transfection (RET) fusion-positive solid tumors will be presented in a rapid oral session at the European Society For Medical Oncology (ESMO) Congress 2026 on Sunday, October 25, 2026.Read Announcement
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