REGENXBIO has received a CRL from the US FDA related to its BLA for RGX-121 to treat MPS II, also called hunter syndrome.

Regenxbio (RGNX) shares fell after the U.S. Food and Drug Administration issued a complete response letter for RGX-121 ...

The FDA has rejected Regenxbio’s biologics license application for RGX-121, an experimental gene therapy for Hunter syndrome. In a complete response letter issued Feb. 7, the FDA cited concerns about ...

Shares in US gene therapy developer Regenxbio (Nasdaq: RGNX) slid more than 17% in after-hours trading on Monday after the ...

ElastiFlow, the leader in open network observability, today announced the General Availability (GA) of Mermin. Purpose-built for DevOps and Site Reliability Engineering (SRE) professionals, Mermin ...

REGENXBIO Inc. RGNX shares are lower during Tuesday's premarket session as the company faces challenges following a recent Complete Response Letter (CRL) from the U.S. Food and Drug Administration ...

Portnox, a leader in passwordless, universal zero trust, today announced a major expansion of its Zero Trust Network Access (ZTNA) solution, extending credential-free access beyond web and on-premises ...

Reco's rapid growth reflects a broader market shift. The company has seen increasing inbound demand from large organizations seeking a way to secure sprawling SaaS and AI environments. Reco today ...

Hexaware Technologies (NSE: HEXT), a global IT services and solutions provider, today announced the launch of Zero License, a new enterprise offering designed to help organizations replace bloated ...

Largest FDA-authorized Phase 2 cell therapy trial conducted in chronic lumbar disc diseaseThe study has enrolled a total of ...

The FDA recommended that REGENXBIO run a new study, treat more patients and include a placebo arm to support a resubmission ...

Researchers at Huntress and Microsoft have shared findings from their analysis of a new SolarWinds Web Help Desk vulnerability.