Bridget Silverman
Managing Editor, US Regulatory Analysis
Latest From Bridget Silverman
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Change Is Constant For Pneumococcal Vaccines: US CDC Prepares For Merck’s V116
As Merck’s 21-valent vaccine approaches its 17 June user fee goal, the US CDC’s vaccine committee is looking at new adult age-based recommendations and bracing for a full pipeline led by GSK’s 24-valent candidate.
US FDA Expects Joint AdComm Briefing Document, Oncology Chief Says
The combined format is the new default for briefing advisory committee members, US FDA Oncology Center of Excellence Director Pazdur declared.
Minimal Residual Disease Gains Max US FDA AdComm Support For Myeloma Trials
The US FDA’s Oncologic Drugs Advisory Committee unanimously agreed that accelerated approvals should be enabled by multiple myeloma trials using MRD as a surrogate endpoint.
Minimal Residual Disease Inches Closer To Supporting Myeloma Accelerated Approvals
US FDA’s oncology advisory committee will discuss two meta-analyses supporting use of MRD as a surrogate endpoint to support accelerated approval in multiple myeloma trials.
J&J’s Carvykti Claims Broadest CAR-T Label In Multiple Myeloma
The second-line indication comes with safety labeling recently approved for BCMA-targeted CAR-T competitor Abecma, particularly around increased early mortality and secondary malignancies.