Bridget Silverman

Garrett Park

Reporter at The Pink Sheet

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Articles

US CDC Panel Recommends Some 50-59 Year-Olds For RSV Vaccination

1 week ago | insights.citeline.com | Bridget Silverman

US CDC Panel Recommends Some 50-59 Year-Olds For RSV VaccinationAll RSV vaccines with US FDA approval for high-risk younger adult patients will be incorporated in US CDC’s Advisory Committee for Immunization Practices recommendations. Merck’s infant RSV antibody is on track for a June voteThe CDC's ACIP expanded the population for adult RSV vaccines and soon could weigh a new option for pediatrics. (Shutterstock)
US FDA’s Advanced Manufacturing Designation Lifts Off With Cellares Cell Shuttle

1 week ago | insights.citeline.com | Bridget Silverman

US FDA’s Advanced Manufacturing Designation Lifts Off With Cellares Cell ShuttleCellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDACellares hopes its Cell Shuttle will ride an Advanced Manufacturing Technology designation to new corporate heights (Shutterstock)
New US FDA Roadmap Moves Closer To Animal Testing Alternatives

1 week ago | insights.citeline.com | Bridget Silverman

New US FDA Roadmap Moves Closer To Animal Testing Alternatives New plan to encourage alternatives to animal testing seeks interagency cooperation to meet more aggressive targets for transformational change than the US FDA’s long-standing program. The US FDA's plans to develop alternatives to animal testing will head in a new direction under the new FDA commissioner. (Shutterstock)
US FDA’s Review Performance Held Steady Despite Stormy First Quarter

2 weeks ago | insights.citeline.com | Bridget Silverman

US FDA’s Review Performance Held Steady Despite Stormy First QuarterOrganizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable. The FDA's review operations stayed on track despite the challenging environment in Q1 2025. (Shutterstock)
‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

3 weeks ago | insights.citeline.com | Bridget Silverman

‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches. Sponsors are hoping approvals will blossom along with the cherry trees. (Shutterstock)
US CDC Vaccines AdComm Rescheduled For April Without Influenza Vote

1 month ago | insights.citeline.com | Bridget Silverman |Sarah Karlin-Smith

US CDC Vaccines AdComm Rescheduled For April Without Influenza VoteThe disruption of CDC’s Advisory Committee on Immunization Practices meeting schedule adds fuel to concerns about potential alterations of the vaccine schedule raised by former FDA Commissioner Scott Gottlieb. The CDC Advisory Committee on Immunization Practices has seen its carefully scheduled process disrupted. (Shutterstock)
Testosterone, TRAVERSE, And A Label Change 15 Years In The Making

1 month ago | insights.citeline.com | Bridget Silverman

Testosterone, TRAVERSE, And A Label Change 15 Years In The Making The Pink Sheet drug review profile investigates the long and rigorous process behind the FDA’s recent relaxation of the cardiovascular safety warning for testosterone products. The label revisions for testosterone are the visible results of an extensive safety review. (Shutterstock)
Testosterone CV Safety, From Signal To Label

1 month ago | insights.citeline.com | Bridget Silverman

Testosterone CV Safety, From Signal To Label The Pink Sheet Drug Review Profile breaks down the FDA's long reckoning with testosterone cardiovascular safety concernsPostmarket safety evaluation of a product is rarely simple and direct. (Shutterstock)
Almost Public: Interagency Meeting Replaces US FDA ‘25-’26 Flu Vaccine AdComm

1 month ago | insights.citeline.com | Bridget Silverman

Almost Public: Interagency Meeting Replaces US FDA ‘25-’26 Flu Vaccine AdComm Only government staff participated in the meeting defining the next season’s influenza vaccine composition after the annual public FDA vaccines advisory committee meeting was cancelled. The selection of influenza strains for the 2025-2026 vaccine took place out of public view. (Shutterstock)
US FDA’s March Approval Candidates Take Aim At Established Markets

1 month ago | insights.citeline.com | Bridget Silverman

US FDA’s March Approval Candidates Take Aim At Established Markets March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome. The FDA's March user fee calendar portends a busy month. (Shutterstock)