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FDA, Rocket Agree on Phase 2 Danon Disease Trial

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Rocket Pharmaceuticals says it has reached an agreement with FDA on a pivotal Phase 2 trial of an investigational gene therapy for...

Safety Concerns Stop Eiger Phase 3 Hepatitis Trial

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Eiger Pharmaceuticals says it is shutting down the Phase 3 LIMT-2 trial of peginterferon lambda in patients with chronic hepatitis...

Supremes May Hear Label Preemption Case: Attorneys

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Two Knobbe Martens attorneys say the Supreme Court could clarify the bounds of federal preemption of state tort claims based on dr...

Include ICH Q12 in Gene Therapy Guidance: ISPE

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The International Society for Pharmaceutical Engineering says FDA should incorporate provisions in an ICH product lifecycle manage...

FDA Clears Wellysis Wearable ECG Patch

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FDA clears the Samsung Wellysis units wearable electrocardiography patch, S-Patch Ex.

White House Credits FDA on Drug Shortages

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The White House credits FDA actions in helping to reduce cancer drug shortages.

Abbott Recalls Proclaim Pulse Generators

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Abbott recalls its Proclaim and Infinity implantable pulse generators due to complaints from patients who are unable to exit MRI m...

Madrigal NDA for Nonalcoholic Steatohepatitis

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FDA accepts for priority review a Madrigal Pharmaceuticals NDA for resmetirom and its use in treating adult patients with nonalcoh...

Oxandrin Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Gemini Laboratories Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, were withdrawn ...

Good Cause Guidance Needs Flexibility: PhRMA

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Pharmaceutical Research and Manufacturers of America says FDA should take a more flexible approach to determining good cause for f...