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CGMP Violations at Zydus Lifesciences Facility

[ Price : $8.95]

FDA warns Zydus Lifesciences Limited about CGMP violations in its production of finished drugs.

Multiple Optikem International Violations Cited

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FDA warns Denver, CO-based Optikem International about Quality System Regulation and other violations in its production of ophthal...

Changes Sought in FDA Misinformation Guidance

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Three trade groups representing companies regulated by FDA recommend changes to a draft guidance on addressing misinformation abou...

FDA Clears Sonic Incytes Velacur Device

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FDA clears Sonic Incytes Velacur Determined Fat Fraction measuring tool.

Priority Voucher Used on Incytes Opzelura

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Federal Register notice: FDA announces that it approved Incytes Opzelura (ruxolitinib) using a rare pediatric disease priority rev...

FDA Mulls More Post-Inspection Feedback: Cavazzoni

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CDER director Patrizia Cavazzoni tells a drug regulatory conference that FDA is considering more opportunities for sponsors to lea...

Cell-Free Nucleic Acid Collector is Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies blood collection devices for cell-free nucleic acids into Class 2.

GSK Highlights Depemokimab Asthma Data

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GSK says data from two clinical trials showed that depemokimab significantly reduces asthma exacerbations in patients with severe ...

Hold Removed on Rezolute Hypoglycemia Drug

[ Price : $8.95]

FDA removes a partial clinical hold against Rezolutes RZ358 (ersodetug), an investigational drug for treating hypoglycemia caused ...

Femasys Fallopian Tube Diagnostic Cleared

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FDA clears a Femasys 510(k) for its diagnostic device for checking the fallopian tubes to confirm permanent birth control placemen...