Regenxbio Inc (RGNX) showcases robust financial positioning and strategic progress in gene therapy, despite challenges in ...

Recently announced positive data from pivotal randomized, placebo-controlled phase 3 clinical trial of CAN-2409 in intermediate-to-high risk, ...

for clesrovimab and set a Prescription Drug User Fee Act (PDUFA) date of 10 June 2025. Data supporting the BLA comes from two trials for which results were presented during the IDWeek meeting in ...

UCART22 Phase 1 dataset and late-stage development strategy expected in the third quarter of 2025; Orphan Drug Designation (ODD) and Rare ...

Financially, Annexon has a strong cash position, providing a runway of 5-8 quarters, but the stock trades almost at cash due ...

OS Therapies, Inc. , a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, today announced that it has been awarded a presentation slot at ...

Discover how outsourcing regulatory submission content development improves efficiency and ensures compliance.

The Baloch Liberation Army (BLA) has issued a chilling 48-hour ultimatum to Pakistan, demanding the release of its prisoners or threatening to execute hostages. This comes after Pakistani forces ...

Additionally, the FDA granted the BLA Priority Review with a Prescription ... industry panel and one-on-one meeting Milestone represents a significant step forward in the development of deramiocel ...

The meeting with MHRA has been scheduled to ... The Company anticipates submitting a Biologics Licensing Application (BLA) to the US FDA for OST-HER2 in osteosarcoma in 2025 and, if approved ...

Pakistan’s military accused neighboring India on Friday of sponsoring insurgents in a restive southwestern province, where an ...

Topline clinical data of the confirmatory registrational study GLOW2 expected in 1Q 2026. <li /> GLOW2 study design mirrors GLOW1 study, ...