Bridget Silverman
Managing Editor, US Regulatory Analysis
Latest From Bridget Silverman
Dengue Swells As US Vaccine Prospects Recede
Sanofi’s voluntary Dengvaxia withdrawal due to low demand leaves the US with no dengue vaccine, even as Puerto Rico declares a public health emergency and global cases rise.
Quality Issues Star In US FDA Complete Response Letter Trio
Rocket Pharmaceuticals’ gene therapy Kresladi, Daiichi Sankyo/Merck’s patritumab deruxtecan, and AbbVie’s foscarbidopa/foslevodopa (ABBV-951) received CRLs because of manufacturing concerns.
US FDA’s Dry July? Few Goal Dates Portend Quiet Month For Approvals
Sun’s deuruxolitinib and Novo Nordisk’s insulin icodec stand out as new molecular entities among the small cluster of US FDA user fee goal dates in July.
Revising Adult RSV Policy: US CDC Moves Toward Risk-Based Vaccine Recommendation
The unpopular shared clinical decision-making policy for RSV vaccines in adults age 60 and older should be replaced by risk-based criteria in people age 60-74 and a universal age-based recommendation at 75 and older, the CDC’s Advisory Committee on Immunization Practices agrees.
Déjà Vu: CBER Director’s Intervention Saves Sarepta’s Elevidys Again
Failure of the EMBARK confirmatory trial convinced US FDA reviewers the Duchenne muscular dystrophy gene therapy did not show clinical benefit, but biologics center director Peter Marks invoked totality of evidence to grant full approval.
US FDA Vaccine Approvals Set Up CDC Votes On Merck’s Capvaxive, Moderna’s mResvia
Advisory Committee on Immunization Practices expected to vote 26-28 June on use of Merck’s 21-valent pneumococcal vaccine, Moderna’s mRNA vaccine for RSV, and an expanded age range for GlaxoSmithKline’s Arexvy RSV vaccine.