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Industry Sounds the Alarm on FDA Staff Cuts

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Industry associations sound alarms and frustrations as they weigh how FDA staff cuts will impact product development, FDA reviews ...

Ocrevus IV Phase 3 Study Misses Primary Endpoint

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Roche says the Phase 3 MUSETTE study found that a higher dose of Ocrevus IV did not provide more benefit than the approved 600 mg ...

Positive EDG-7500 Heart Drug Phase 2 Results

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Edgewise Therapeutics says its EDG-7500 achieved positive results in the four-week CIRRUS-HCM trial in hypertrophic cardiomyopathy...

RFK Jr. Invited to Senate Hearing on HHS Reorganization

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The Senate HELP Committee invites HHS secretary RFK, Jr., to testify on his reorganization of the department.

FDA Misses Novavax Covid Vaccine Review Action

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FDA misses its 4/1 user fee review action target date on a Novavax BLA seeking full approval for its current Covid-19 vaccine.

FDA Remaking Inspection Priorities in Wake of Trump Cuts

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FDA says it is reprioritizing planned inspections for the rest of the year due to challenges it faces after 170 administrative and...

Medivis Spinal Navigation Device Cleared

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FDA clears a Medivis 510(k) for its Spine Navigation platform that uses augmented reality and artificial intelligence (AI) to assi...

FDA in Upheaval as Staff Layoffs Begin

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HHS begins terminating FDA employees, with many receiving email notifications in the early morning hours or being denied entrance ...

Apellis Files Empaveli sNDA in Rare Kidney Diseases

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FDA accepts for priority review an Apellis Pharmaceuticals supplemental NDA for Empaveli (pegcetacoplan) for treating two severe a...

RFK Jr. Upends His Promise to Enhance Transparency

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Despite HHS secretary Robert F. Kennedy, Jr.s promises to boost transparency at HHS and its health agencies, staff cuts now occurr...