Richard Pazdur is eager for a conversation about how to improve the Accelerated Approval pathway. The OCE director welcomes aducanumab’s approval – both on its own terms but also as an opportunity to broaden the discussion.
The US Food & Drug Administration’s top oncology review manager has a lot to say about the agency’s biggest neurological drug approval in decades.
During a 8 June interview with Prevision Policy’s Kate Rawson, Oncology Center of Excellence Director Richard Pazdur couldn’t wait...
The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.
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 US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.
The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.
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.
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.
