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Human Drugs

Ex-CDC Chief Says FDA Facing Similar Political Pressure

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

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Human Drugs

Are FDA Advisory Committees Doomed?

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

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Medical Devices

Exactech Pays $8 Million in Whistleblower Cases

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

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Human Drugs

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

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

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Human Drugs

J&J Reports Positive Data in Psoriasis Drug

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

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Human Drugs

sGERD Drug Development Guidance

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

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Human Drugs

Developing Disseminated Coccidiodomycosis Drugs

FDA publishes a draft guidance to help sponsors with clinical trials for drugs to treat disseminated coccidiomycosis.

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Human Drugs

AstraZeneca Fasenra Trial Misses in COPD

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

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Human Drugs

DoJ Charges Man in Misbranded Rx Drug Case

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

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Human Drugs

4 Observations in Lupin Inspection

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