Aseptic processing demands reliable, robust, and validated analytical methods to ensure sterility, safety, and quality, ...

The pharmaceutical industry is calling on the FDA to modernise how it tracks the long-term safety and efficacy of cell and ...

Validated next-generation sequencing soon will become necessary in ensuring the safety and efficacy of cell and gene ...

Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...

Novel capsid technology to enable convenient delivery in the doctor’s office of IKAR-003 for intermediate AMD, designed to prevent progression to sight-threatening disease ...

The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...

Real-world, 12-month results demonstrated efficacy, safety and durability for faricimab as a treatment for retinal vein ...

Real-world evidence highlights the effectiveness of teclistamab and elranatamab in treating frail multiple myeloma patients, paving the way for future therapies.

Delgocitinib cream and dupilumab have similar efficacy at 16 weeks of treatment in patients with moderate to severe atopic hand eczema.

Good Clinical Practice (GCP), the bedrock of ethical and high-quality clinical research, guides operations among sponsor companies, contract research organisations (CROs), investigator sites, and ...

Novel small molecule inhibitors show promising efficacy in endometrial cancer, with ongoing trials expanding treatment ...

Telitacicept, a dual inhibitor of the cytokines B-lymphocyte stimulator and a proliferation-inducing ligand, showed efficacy ...