FDA– tag –
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FDA Decision on Nanocapsulated Sirolimus and Pegadricase Combination NASP for Gout Treatment Expected June 27, 2026
Prime Therapeutics - Portal USA Overview The U.S. FDA is scheduled to announce its decision on NASP (nanocapsulated sirolimus + pegadricase), a treatment for refractory gout, on June 27, 2026. NASP is an intravenous formulation combining... -
Beam Therapeutics Secures FDA IND Clearance for Liver-Targeted LNP Formulation BEAM-304 as PKU Treatment, Phase 1/2 Trial Imminent
Business Wire / Nasdaq USA Overview Beam Therapeutics announced FDA Investigational New Drug (IND) clearance for BEAM-304, its lead candidate for Phenylketonuria (PKU). BEAM-304 is a liver-targeted lipid nanoparticle (LNP) formulated bas... -
Medyra Health Bolsters Therapeutic Development and Evaluation by Leveraging Real-World Evidence (RWE)
Medyra Health USA Overview Medyra Health outlines its RWE-focused therapeutic approach, emphasizing the generation of high-quality real-world evidence to enhance therapy evaluation and development. The company specializes in RWE study de... -
Orca Bio Expands East Coast Manufacturing Capacity and Triples West Coast Workforce Ahead of Potential Orca-T® Commercial Launch, with FDA PDUFA Date Set for July 6, 2026
Business Wire USA Overview Orca Bio announced significant manufacturing expansions for its investigational cell therapy, Orca-T®, in anticipation of its commercial launch. This includes establishing new East Coast manufacturing capacity ... -
Penn Medicine Leads Cell and Gene Therapy Field, Pioneering Foundational Research for CAR T-Cell Therapies
Penn Medicine USA Overview Penn Medicine highlights its profound expertise in cell and gene therapies, including its foundational work in CAR T-cell therapy. The institution explains how these "biologics" target the root cause of illness... -
Cellares and Ori Biotech Lead Automated Cell Therapy Production Market with FDA Advanced Manufacturing Technology Designation
Fierce Pharma USA Overview A Tracxn report highlights Cellares and Ori Biotech as dominant leaders in automated cell therapy production, both holding FDA's Advanced Manufacturing Technology (AMT) designation. Their closed systems aim to ... -
Qihan Biotech’s Universal Dual-Target Hypoimmune CAR-T Therapy QT-019B Receives FDA RMAT and Breakthrough Therapy Designations
PackGene Biotech China Overview Qihan Biotech's universal dual-target CAR-T therapy, QT-019B, has received both FDA Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy Designations (BTD). This off-the-shelf allogeneic ... -
FDA Unleashes Real-Time Clinical Trials: An AI-Driven Revolution for Faster Drug Development
ICON plc アイルランド Overview The U.S. FDA has launched its Real-time Clinical Trials (RTCT) initiative, a pivotal program designed to dramatically accelerate drug development. By enabling near real-time data sharing with regulators and... -
Minaris Strengthens Philadelphia GMP Facility, Integrating Cell & Gene Therapy Manufacturing and Testing to Streamline Production
BriefGlance.com USA Overview Minaris, a leading CDMO, has significantly upgraded its GMP cell banking suite at its Philadelphia facility, aiming to streamline cell and gene therapy production. This expansion integrates manufacturing and ... -
Intellia Therapeutics Reports “Paradigm-Shifting” Phase 3 Data for Lonvoguran Ziclumeran, Achieving 87% Reduction in HAE Attacks with Single In Vivo CRISPR Dose
Fierce Biotech USA Overview Intellia Therapeutics announced groundbreaking Phase 3 HAELO trial data for lonvoguran ziclumeran (lonvo-z), an *in vivo* CRISPR gene-editing therapy for hereditary angioedema (HAE). This one-time treatment de...
