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Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company Kelley-Ross Compounding.

FDA Adds 4 Tropical Disease Designations

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Federal Register notice: FDA determines that chikungunya virus disease, Lassa fever, rabies, and cryptococcal meningitis satisfy i...

Pneumocystis Pneumonia Not a Tropical Disease: FDA

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Federal Register notice: FDA determines that Pneumocystis pneumonia does not meet statutory criteria for designation as a tropical...

FDA Proposes Banning 3 Bulk Drugs from Compounding

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FDA proposes to ban three bulk drug substances bumetanide, nicardipine hydrochloride, and vasopressin from its list of bulk drug...

Problems Seen in Draft Pressor Effect Guidance

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Stakeholders ask for clarifications to an FDA draft guidance on assessing drugs pressor effects.

Data-Driven Psychiatry Possible: Study

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Former FDA commissioner Robert Califf and Verily Life Sciences researchers suggest it is possible to use digital measurement tools...

Shires Takhzyro Approved for Hereditary Angioedema

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FDA approves a Shire BLA for Takhzyro (lanadelumab-flyo) injection for preventing hereditary angioedema attacks in patients 12 yea...

FDA Approves Imbruvica and Rituximab for Rare Disease

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FDA approves Janssen Biotech and Pharmacyclics Imbruvica (ibrutinib) in combination with Genentechs rituximab for treating Waldens...

CathWorks 510(k) for Fractional Flow Reserve Device

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CathWorks files a 510(k) for its CathWorks FFRangio System, a fractional flow reserve device that is intended to deliver objective...

Warning Letter Sent to Zimmer Biomet Subsidiary

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FDA 8/24 sends a Warning Letter to a Zimmer Biomet subsidiarys manufacturing facility in Warsaw, IN over GMP issues documented in ...