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Positive EDG-7500 Heart Drug Phase 2 Results

[ Price : $8.95]

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

[ Price : $8.95]

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

FDA Misses Novavax Covid Vaccine Review Action

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

FDA Says Rex Implants Illegally Marketing Devices

[ Price : $8.95]

FDA warns Columbus, OH-based Rex Implants that it is illegally manufacturing and distributing three medical devices.

Bausch + Lomb Recalls enVista Intraocular Lenses

[ Price : $8.95]

Bausch + Lomb recalls all enVista intraocular lenses due to increasing adverse event reports of toxic anterior segment syndrome as...

Axsome Solriamfetol Misses Primary Endpoint

[ Price : $8.95]

Axsome Therapeutics says its solriamfetol missed the primary endpoint in a Phase 3 proof-of-concept trial to treat major depressiv...

Compass Therapeutics Reports on Tovecimig Trial Data

[ Price : $8.95]

Compass Therapeutics reports statistically significant top-line data on the primary efficacy endpoint from its COMPANION-002 trial...

3 Observations on SKNV Outsourcing FDA-483

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FDA releases the form FDA-483 with three observations from an inspection at the Pompano Beach, FL-based SKNV outsourcing facility.