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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...

Developing Disseminated Coccidiodomycosis Drugs

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FDA publishes a draft guidance to help sponsors with clinical trials for drugs to treat disseminated coccidiomycosis.

Lillys Oral Diabetes Drug Outperforms Rival in Head-to-Head Trial

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Eli Lilly reports that it oral diabetes drug orforglipron achieved stronger blood sugar and weight loss results than Novo Nordisks...

Ex-CDC Chief Says FDA Facing Similar Political Pressure

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Former CDC director Susan Monarez says FDA and other health agencies are facing similar political pressure that she experienced to...

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...

4 Observations in Lupin Inspection

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FDA releases the form FDA-483 with four observations from an inspection at the Lupin drug manufacturing facility in Madhya Pradesh...

Becton Dickinson Expands Alaris Pump Recall

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Becton Dickinson expands its Class 1 recall of its Alaris Pump Module model 8100 to include 15 additional infusion sets, citing po...

FDA DTC Push Cites GLP-1 Drugs in 4 Letters

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FDAs ongoing crack down on drug direct-to-consumer promotional activities results in three just-released Warning Letters to Eli Li...