Roche (RHHBY) FDA Approvals $60.95 +1.77 (+2.99%) As of 03:59 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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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. From Our PartnersThe AI Infrastructure Rush Is ON — Watch VDTAVertical Data Inc (OTCQB: VDTA) is building the layers beneath the AI boom - GPU hardware and financing, manag...Trading Wire | SponsoredI'm handing you this one freeElon Musk doesn't own the chip powering every Tesla, every Starlink dish, and every AI satellite he builds, he...Behind the Markets | SponsoredMy public warning after 55 years of watching the marketsDr. Martin D. 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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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