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Accelerated Approval Works: Friends of Cancer Research

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

Tariffs Could Hurt Drug Supply: HuffPost

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

GSKs Nucala Approved for Certain COPD Patients

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

Moderna Withdraws Pending BLA for Flu/Covid Vaccine

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

QS Violations in NeuroSync Inspection

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

Ethicon Endo-Surgery Recalls Surgical Stapler

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

Microspecialties Quality System Issues

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

Expand mRNA Covid Vaccine Warnings: FDA

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

Bipartisan Bill to Codify Trump Drug Price Order

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

Panel is Split on UroGens Bladder Cancer Drug

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FDAs Oncologic Drugs Advisory Committee offers a split vote on whether UroGen Pharmas NDA for mitomycin intravesical solution demo...