Press Releases
Page 3 • 12 itemsAccess critical pharma & biotech press releases. Stay ahead on drug approvals, clinical trials, M&A, and regulatory updates impacting global markets.
Stoke Therapeutics Zorevunersen Shows Promise for Dravet Syndrome Treatment Ahead of Q1 2026 Results
Stoke Therapeutics prepares Q1 2026 earnings call featuring Zorevunersen, an investigational antisense therapy targeting Dravet syndrome's underlying cause.
uniQure AMT-130 Gene Therapy Advances Toward UK Approval for Huntington's Disease Treatment
uniQure completes successful UK MHRA pre-submission meeting for AMT-130 Huntington's disease gene therapy, targeting Q3 2026 marketing authorization application.
Northwest Biotherapeutics Appoints Dr. Annalisa Jenkins as Strategic Adviser for DCVax Cancer Vaccine Development
Northwest Biotherapeutics names Dr. Annalisa Jenkins as Strategic Adviser to advance DCVax dendritic cell cancer vaccine platform with 25+ years biopharma experience.
Cerus Corporation INTERCEPT Blood System Advances Through European Regulatory Review and Phase 3 Trials
Cerus Corporation's INTERCEPT Blood System progresses through European regulatory review while Phase 3 RedeS trial readout and new INT200 device submission planned.
Bio-Rad Q1 2026 Results Show IVDR Compliance Costs Impact European Diagnostics Operations
Bio-Rad reports Q1 2026 financial results highlighting increased costs from EU IVDR compliance and product portfolio rationalization in diagnostics market.
FDA Advisory Committee Recommends AstraZeneca's TRUQAP for PTEN-Deficient Metastatic Prostate Cancer
FDA's Oncologic Drugs Advisory Committee recognizes favorable benefit-risk profile for TRUQAP (capivasertib) in PTEN-deficient metastatic prostate cancer treatment.
Alkeus Pharmaceuticals Presents Gildeuretinol Data for Stargardt Disease at ARVO 2026
Alkeus Pharmaceuticals announces clinical data presentation for investigational oral gildeuretinol treating Stargardt disease at ARVO 2026 meeting.
SetPoint Medical Begins Multiple Sclerosis Trial for Setpoint System Neuroimmune Therapy
SetPoint Medical enrolls first patients in pilot study testing Setpoint System for relapsing-remitting multiple sclerosis treatment with FDA approval.
Emergent BioSolutions Reports Q1 2026 Financial Results: Biodefense Company Updates Revenue Performance
Emergent BioSolutions releases first quarter 2026 financial results, providing insights into the biodefense and pharmaceutical company's performance.
Telix Pharmaceuticals' TLX101-Px (Pixlumi) Brain Cancer Imaging Drug Accepted for European Review
Telix Pharmaceuticals' TLX101-Px (Pixlumi) glioma imaging drug enters 210-day European regulatory review after MAA acceptance, targeting brain cancer diagnosis.
HUTCHMED's Sovleplenib Receives Priority Review and Breakthrough Designation in China for Rare Blood Disorder
HUTCHMED announces NDA acceptance with priority review status for sovleplenib to treat warm antibody autoimmune hemolytic anemia in China.
FDA Real-World Evidence Framework Shifts $10B Toward Validated Medtech Platforms Like VentriPoint
FDA's new real-world evidence requirements for medical devices create $10B market shift favoring established platforms with proven performance data.