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Medical Devices

Serious Research Issues at United Health Products: FDA

FDA warns Mt. Laurel, NJ-based United Health Products about serious violations in its clinical study of the CelluSTAT absorbable hemostat.

Animal Drugs

Accelerated Approval Works: Friends of Cancer Research

A Friends of Cancer Research online data analysis shows the FDA accelerated approval program is working as designed to speed innovative drugs to the m...

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Human Drugs

Tariffs Could Hurt Drug Supply: HuffPost

A HuffPost report says a tariff on imported drugs could lead to shortages of medications that patients need.

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Human Drugs

GSKs Nucala Approved for Certain COPD Patients

FDA approves GSKs Nucala (mepolizumab) as an add-on maintenance treatment for certain adults with chronic obstructive pulmonary disease.

Biologics

Moderna Withdraws Pending BLA for Flu/Covid Vaccine

Moderna, at FDAs urging, voluntarily withdraws a pending BLA for mRNA-1083, its flu/COVID combination vaccine candidate.

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Medical Devices

QS Violations in NeuroSync Inspection

FDA warns Holliston, MA-based NeuroSync about Quality System regulation and other violations in its manufacturing of the Eye-Sync eye assessment medic...

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Medical Devices

Ethicon Endo-Surgery Recalls Surgical Stapler

Johnson & Johnsons Ethicon Endo-Surgery recalls its Endopath Echelon Vascular White Reload for Advanced Placement Tip surgical stapler due to increase...

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Medical Devices

Microspecialties Quality System Issues

FDA warns Middletown, CT-based Microspecialties about Quality System violations in its work as a contract manufacturer of several ophthalmic surgical ...

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Biologics

Expand mRNA Covid Vaccine Warnings: FDA

FDA tells Pfizer and Moderna to strengthen the Warnings in their Covid-19 vaccines related to a possible adverse heart effect in young males.

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Human Drugs

Bipartisan Bill to Codify Trump Drug Price Order

Four House members introduce bipartisan legislation to legalize major provisions in President Trumps drug pricing executive order.