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Sarepta Scraps Next-Gen Duchenne Drug

[ Price : $8.95]

Based on safety concerns, Sarepta says it is discontinuing the development of SRP-5051 (vesleteplirsen) for treating patients with...

FDA OKs LumiThera Dry AMD Treatment

[ Price : $8.95]

FDA grants de novo authorization to LumiTheras Valeda light delivery treatment for dry age-related macular degeneration.

Caris Companion Diagnostic for Cancer Approved

[ Price : $8.95]

FDA approves Caris Life Sciences MI Cancer Seek and its use as a companion diagnostic to identify cancer patients for treatment wi...

ACLA Views on PCCP Draft Guidance

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The American Clinical Laboratory Association submits comments to an FDA draft guidance on medical device predetermined change cont...

RFK Jr. Says Some FDA Departments Have to Go

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In an interview the day after the election, president-elect Donald Trumps top health advisor Robert F. Kennedy Jr. says there are ...

Breakthrough Designation for SeaStar Dialysis Device

[ Price : $8.95]

FDA grants a fourth breakthrough device designation for SeaStar Medicals Selective Cytopheretic Device.

9 Observations in Staska Pharmaceuticals FDA-483

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FDA releases the form FDA-483 with nine observations from an inspection at the Staska Pharmaceuticals outsourcing facility in Benn...

Clozapine REMS Curbs Treatment: Comments

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Three mental health stakeholders call on two FDA advisory committees to recommend changes to the clozapine REMS.

Zeta Gets Navigation System Improvements Cleared

[ Price : $8.95]

FDA clears a Zeta Surgical 510(k) for its Zeta Navigation System for use with expanded instruments and enhanced hospital connectiv...

Advisors Asked for ProSense Benefits, Risks

[ Price : $8.95]

FDA raises questions to be considered by members of its General and Plastic Surgery Advisory Committee about IceCare Medicals ProS...