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DoJ Charges Man in Misbranded Rx Drug Case

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The Department of Justice charges David Ralph Webber with smuggling and selling misbranded prescription drugs marketed as sexual e...

sGERD Drug Development Guidance

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FDA publishes a guidance to help sponsors with clinical trials for drugs to treat symptomatic nonerosive gastroesophageal reflux d...

J&J Reports Positive Data in Psoriasis Drug

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Johnson & Johnson reports favorable data from the Phase 3 ICONIC-ADVANCE 1 and 2 studies that showed its experimental psoriasis dr...

Exactech Pays $8 Million in Whistleblower Cases

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The Justice Department says Gainesville, FL-based Exactech is paying $8 million to resolve four whistleblowers allegations that th...

Are FDA Advisory Committees Doomed?

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FDA Matters founder Steven Grossman speculates on why FDA commissioner Martin Makary may want to limit or eliminate the role of ad...

AstraZeneca Fasenra Trial Misses in COPD

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AstraZeneca reports that data from a Phase 3 trial of Fasenra (benralizumab) did not achieve the primary endpoint in patients with...

Concerning DTC Ad Misbrands Hizentra: FDA

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FDA warns CSL Behring that a direct-to-consumer TV spot for its Hizentra overstates the drugs effectiveness and minimizes its risk...

Multiple Violations in Illegal Marketing of SeniorLife.AI

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FDA warns Bellevue, WA-based SeniorLife.AI about multiple violations in its illegal marketing of an artificial intelligence-based ...

Alert on Medline Kits with Medtronic Heart Catheter

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FDA issues an early alert about a Medline recall for specific lots of Medline Kits containing Medtronic DLP Left Heart Vent Cathet...

CGMP Violations in Somerset Therapeutics Inspection

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FDA warns Indias Somerset Therapeutics about CGMP and Field Alert Reporting violations in its production of finished drugs.