Chester County News and Community Website
MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) Chief Executive Officer Shankar Musunuri will discuss regulatory approval and commercialization of cell and gene therapies at an industry conference Oct. 6 in …
Ocugen CEO to Address Gene Therapy Commercialization Read More MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) has secured provisional approval and priority designation in The Bahamas for OCU400, creating a pathway to provide its investigational gene therapy to retinitis …
Ocugen Wins Bahamas Priority Path for OCU400 Gene Therapy Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration approved Fayuvi, a one-time gene therapy from Ultragenyx Pharmaceutical Inc., as the first treatment for children with mucopolysaccharidosis type IIIA, providing …
FDA Approves First Treatment for Sanfilippo Syndrome Type A Read More
CONSHOHOCKEN, PA — Cencora has launched a service to help health systems build and scale cell and gene therapy programs, targeting operational and financial barriers that can limit hospitals’ ability …
Cencora Expands Cell and Gene Therapy Support for Health Systems Read More MALVERN, PA — Ocugen Inc. (Nasdaq: OCGN) has dosed the first patient in a global Phase 3 trial of OCU410, moving its one-time gene therapy for geographic atrophy into pivotal …
Malvern’s Ocugen Starts Pivotal Trial for Eye Gene Therapy Read More MALVERN, PA — The U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy designation to Ocugen Inc.’s experimental OCU410 gene therapy for geographic atrophy, giving the blindness treatment access …
FDA Gives Ocugen Gene Therapy Expedited Regulatory Status Read More
DOYLESTOWN, PA — Hatch BioFund has invested in Optimeos Life Sciences, a Princeton University spinout developing a nanoparticle platform for delivering gene therapies and other biologic medicines, expanding the Pennsylvania …
Hatch BioFund Invests in Gene Delivery Startup Optimeos Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration has expanded approval of the gene therapy Casgevy to include children as young as 2 with sickle cell disease or transfusion-dependent …
FDA Expands Casgevy Approval to Children as Young as 2 Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has released draft guidance that could shorten development timelines for gene therapies by allowing drugmakers to make greater use of existing …
FDA Issues Gene Therapy Guidance Aimed at Faster Reviews Read More
PHILADELPHIA, PA — iECURE announced that new clinical data from its ongoing OTC-HOPE trial evaluating ECUR-506 in neonatal-onset ornithine transcarbamylase deficiency will be presented this month at two medical conferences.
iECURE Reports Early OTC Gene Therapy Trial Results Read More