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FDA publishes a draft guidance to help sponsors with clinical trials for drugs to treat disseminated coccidiomycosis.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

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

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

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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Concerning DTC Ad Misbrands Hizentra: FDA

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

Medical Devices

Multiple Violations in Illegal Marketing of SeniorLife.AI

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

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Medical Devices

Alert on Medline Kits with Medtronic Heart Catheter

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

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Human Drugs

CGMP Violations in Somerset Therapeutics Inspection

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

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Human Drugs

China Speeding Drug Approvals: CIRS Briefing

A Center for Innovation in Regulatory Science briefing paper stresses Chinas faster drug approvals and the need for sponsors to make coordinated submi...

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Marketing

40 DTC Untitled Letters Posted by FDA

FDA releases 40 cease and desist (untitled) letters to drug companies that the agency said were issued earlier this month when it unveiled a major pus...