The three-day advisory committee was intended to ‘put companies on notice’ about the importance of confirmatory trials. The result? Mission accomplished.
The immediate impact of the US Food & Drug Administration’s oncology advisory committee’s consideration of six “dangling” Accelerated Approvals in the PD-1 class – and the underlying message that FDA was getting serious about AA drugs that had failed confirmatory studies – was for a sponsor to volunteer to remove an indication from the market.
“I was shocked,” Oncology Center of Excellence and Director Rick Pazdur said during an 8 June interview with Prevision...
The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.
The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.
The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.
Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.
The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.
A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.
Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.
