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Alert on Abbotts TactiFlex Ablation Catheter

[ Price : $8.95]

FDA issues an alert after becoming aware that Abbott issued a letter to customers recommending updated instructions when removing ...

6 Observations in Fagron Outsourcing Inspection

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FDA releases the form FDA-483 with six observations from an inspection at Wichita, KS-based Fagron Compounding Services.

FDA Approves 2 Biocon Denosumab Biosimilars

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FDA approves Biocon Biologics biosimilars for Amgens Prolia and Xgeva.

Safety Labeling Changes Guidance

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FDA issues a draft guidance revising and updating a 2013 guidance on safety labeling changes when new safety information becomes a...

Committee Advances Pediatric Voucher Reauthorization

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The House Energy and Commerce Committee unanimously approves legislation to reauthorize FDAs Rare Pediatric Disease Priority Revie...

FDA OKs Expanded Labeling for Asthma Drug

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FDA approves an AstraZeneca supplemental NDA for Airsupra (albuterol/budesonide) to expand the drugs labeling to reflect a 46% red...

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FDA publishes a draft guidance to help sponsors with clinical trials for drugs to treat disseminated coccidiomycosis.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