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

Any company looking to work with a CDMO should begin by defining its own product’s development requirements. For example, a ...

In the evolving landscape of pharmaceutical production, fill-finish contract manufacturing has become a crucial area of focus ...

Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr ...

Enrollment completed in VIRAGE Phase 2b clinical trial of VCN-01 in metastatic pancreatic ductal adenocarcinoma (PDAC); topline data expected ...

CellProthera, a regenerative cell therapy developer specializing in ischemic diseases, announced it will be presenting next week at Terrapinn’s Advanced Therapies Congress 2025, held in London. Ibon ...

Feedback from the FDA and EMA is being incorporated into the design of a Phase 3 ... advance our VCN-01 program in retinoblastoma, expand GMP scale-up manufacturing activities for VCN-01, and continue ...

Lonza will leverage its expertise in exosome development and analytical services to define a GMP-compliant process for Exo-101 production.

Feedback from the FDA and EMA is being incorporated into the design of a Phase 3 study protocol and an End-of-Phase 2 meeting with the FDA to discuss the proposed Phase 3 study will be requested ...

The global stem cell therapy market is poised for remarkable growth, with revenues projected to escalate from USD 394.50 million in 2024 to USD 2,612.92 million by 2033, reflecting a compelling ...

The EMA is implementing major changes to accelerate drug approvals in the EU, addressing delays that affect patients and businesses alike. Following a turbulent period marked by Brexit and the ...