Myriad Genetics (MYGN) FDA Approvals $3.06 +0.21 (+7.17%) As of 10:50 AM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock Myriad Genetics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Myriad Genetics (MYGN). Over the past two years, Myriad Genetics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as niraparib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Niraparib FDA Regulatory Events Niraparib is a drug developed by Myriad Genetics for the following indication: patients with advanced ovarian cancer. 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. FDA approved - March 17,2026Fda Approved Drug: niraparibAnnounced Date: March 17, 2026Indication: patients with advanced ovarian cancer.AnnouncementMyriad Genetics, Inc announced that the U.S. Food and Drug Administration (FDA) has approved the MyChoice® CDx Test as the Companion Diagnostic (CDx) for Zejula® (niraparib), a PARP inhibitor from GSK, for patients with advanced ovarian cancer.AI SummaryMyriad Genetics announced that the U.S. Food and Drug Administration has approved the MyChoice® CDx Test as the companion diagnostic for Zejula® (niraparib), GSK’s PARP inhibitor, for patients with advanced ovarian cancer. The approval allows MyChoice CDx to be used to identify patients whose tumors show homologous recombination deficiency (HRD), helping clinicians determine who is likely to benefit from Zejula treatment. Myriad said the decision highlights its leadership in ovarian cancer diagnostics and the clinical value of broad HRD testing. Nearly half of patients with advanced ovarian cancer have HRD-positive tumors, so identifying these patients is key to choosing appropriate PARP inhibitor therapy and personalizing treatment plans. By providing robust genomic information, MyChoice CDx aims to guide treatment decisions and improve matching of patients to targeted therapy.Read Announcement Myriad Genetics FDA Events - Frequently Asked Questions Has Myriad Genetics received FDA approval? As of now, Myriad Genetics (MYGN) has not received any FDA approvals for its therapy in the last two years. What drugs has Myriad Genetics submitted to the FDA? In the past two years, Myriad Genetics (MYGN) has reported FDA regulatory activity for niraparib. What is the most recent FDA event for Myriad Genetics? The most recent FDA-related event for Myriad Genetics occurred on March 17, 2026, involving niraparib. The update was categorized as "FDA approved," with the company reporting: "Myriad Genetics, Inc announced that the U.S. Food and Drug Administration (FDA) has approved the MyChoice® CDx Test as the Companion Diagnostic (CDx) for Zejula® (niraparib), a PARP inhibitor from GSK, for patients with advanced ovarian cancer." What conditions do Myriad Genetics' current drugs treat? Currently, Myriad Genetics has one therapy (niraparib) targeting the following condition: patients with advanced ovarian cancer.. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Acurx Pharmaceuticals FDA EventsAkebia Therapeutics FDA EventsAltimmune FDA EventsEstrella Immunopharma FDA EventsNiagen Bioscience FDA EventsOmeros FDA EventsOSR FDA EventsRocket Pharmaceuticals FDA EventsTonix Pharmaceuticals FDA EventsZai Lab FDA EventsEli Lilly and Company FDA EventsClearPoint Neuro FDA EventsMoleculin Biotech FDA EventsAprea Therapeutics FDA EventsCapricor Therapeutics 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 Zenas BioPharma FDA Events Innoviva FDA Events MannKind FDA Events Novavax FDA Events Lexicon Pharmaceuticals FDA Events OPKO Health FDA Events Geron FDA Events Rigel Pharmaceuticals FDA Events Achieve Life Sciences FDA Events Ironwood Pharmaceuticals FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:MYGN last updated on 3/18/2026 by MarketBeat.com Staff. 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FDA approved - March 17,2026Fda Approved Drug: niraparibAnnounced Date: March 17, 2026Indication: patients with advanced ovarian cancer.AnnouncementMyriad Genetics, Inc announced that the U.S. Food and Drug Administration (FDA) has approved the MyChoice® CDx Test as the Companion Diagnostic (CDx) for Zejula® (niraparib), a PARP inhibitor from GSK, for patients with advanced ovarian cancer.AI SummaryMyriad Genetics announced that the U.S. Food and Drug Administration has approved the MyChoice® CDx Test as the companion diagnostic for Zejula® (niraparib), GSK’s PARP inhibitor, for patients with advanced ovarian cancer. The approval allows MyChoice CDx to be used to identify patients whose tumors show homologous recombination deficiency (HRD), helping clinicians determine who is likely to benefit from Zejula treatment. Myriad said the decision highlights its leadership in ovarian cancer diagnostics and the clinical value of broad HRD testing. Nearly half of patients with advanced ovarian cancer have HRD-positive tumors, so identifying these patients is key to choosing appropriate PARP inhibitor therapy and personalizing treatment plans. By providing robust genomic information, MyChoice CDx aims to guide treatment decisions and improve matching of patients to targeted therapy.Read Announcement
