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Identifying disease biomarkers in rural and medically underserved populations through breath-based diagnostics devices is the goal of the FDA’s partnership with the Bill & Melinda Gates Foundation, CDRH announced Wednesday. Read More
Changes to the Risk Evaluation and Mitigation Strategy (REMS) for all six approved CAR-T cell therapies remove the requirement for providers to engage in specific educational activities and allow them to report adverse events directly to the FDA’s MedWatch reporting system. Read More
Merck and Daiichi Sankyo’s non-small cell lung cancer drug suffered a setback with the companies’ receipt of an FDA complete response letter (CRL) identifying third party manufacturer inspection issues as the reason for rejecting the drug application. Read More
This month Takeda struggles to find the bright side of disappointing phase 3 data, Pfizer touts “unprecedented” lung cancer success, NS Pharma’s Duchenne muscular dystrophy drug fails in phase 3, and GLP1-agonists are not only reducing mortality, but getting a subdermal device makeover. Read More