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Horizon Misses on Lupus Phase 2 Endpoint

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Horizon Therapeutics says a Phase 2 clinical trial evaluating daxdilimab for treating systemic lupus erythematosus failed to meet ...

Nesa Medtech Fibroid Mapping App Cleared

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FDA clears a Nesa Medtech 510(k) for its Fibroid Mapping Reviewer Application (FMRA), intended for use by physicians to generate a...

FDA OKs Verrica NDA for Molluscum Topical

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FDA approves a Verrica Pharmaceuticals NDA for Ycanth (cantharidin) topical solution for treating molluscum contagiosum (molluscum...

Datascope Recalls Cardiosave IntraAortic Pumps

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Datascope recalls its Cardiosave Rescue IntraAortic Balloon Pumps because of the potential for an unexpected shutdown of the pump....

ADC Therapeutics Discontinues Phase 2 Trial

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ADC Therapeutics says it is discontinuing its Phase 2 LOTIS-9 clinical trial evaluating Zynlonta (loncastuximab tesirine-lpyl) and...

Bufferin NDA Withdrawn by FDA

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Federal Register notice: FDA withdraws approval of an NDA for Bufferin (aspirin) tablets because the application holder has failed...

FDA OKs Emergents Anthrax Vaccine

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FDA approves an Emergent BioSolutions BLA for Cyfendus (anthrax vaccine adsorbed, adjuvanted) for anthrax post-exposure prophylaxi...

Peter Stoll Guilty on Medical Device Felony Count

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Former medical device regulatory affairs specialist Peter Stoll pleads guilty on one felony count for distributing medical devices...

CDERs Rosemary Roberts is Retiring

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CDER Counterterrorism and Emergency Coordination Staff director Rosemary Roberts announces her retirement this month.

BIO Backs Rare Disease Endpoint Pilot

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The Biotechnology Innovation Organization says FDAs new Rare Disease Endpoint Advancement Pilot Program will provide greater clari...