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Kenvue Urges FDA to Reject Acetaminophen Petition

[ Price : $8.95]

Kenvue urges FDA to deny a recent citizen petition requesting updates to the pregnancy warning on acetaminophen products.

FDA Drug Approval Trends Slipping: Financial Analysts

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A new report by RBC Capital Markets finds a slowdown in FDA drug approvals, a rise in rejected applications, and an increase in de...

Celltrions Yuflyma Expanded Approval for Younger Patients

[ Price : $8.95]

FDA approves expanded indications for Celltrions Yuflyma (adalimumab-aaty) to include treating hidradenitis suppurativa in adolesc...

9 Vouchers Awarded Under New Priority Review Pilot

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FDA names the first nine voucher recipients under the recently launched Commissioners National Priority Voucher pilot review progr...

FDA OKs Iron-Based MRI Contrast Agent

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FDA approves Azurity Pharmaceuticals Ferabright (ferumoxytol injection), an iron-based contrast agent for magnetic resonance imagi...

Sen. Banks Presses FDA to Ramp Up Foreign Inspections

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Sen. Jim Banks (R-IN) urges FDA to step up inspections of pharmaceutical manufacturing facilities abroad, citing persistent qualit...

Autism Warning Marks Sharp Break from Standards: Attorneys

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Attorneys from Mintz warn that FDAs recent safety communication on acetaminophen and autism may signal a departure from long-stand...

FDA Grants Priority Review to J&Js Akeega sNDA

[ Price : $8.95]

FDA accepts for priority review a Johnson & Johnson supplemental NDA for Akeega (niraparib and abiraterone acetate dual-action tab...

Novartis Fabhalta Slows Kidney Function Decline

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Novartis reports that a Phase 3 trial of its oral complement inhibitor Fabhalta (iptacopan) showed the therapy slowed kidney funct...

Create Drug Facts Box for DTC Ads: Column

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Two academic researchers urge FDA to require a Drug Facts box in direct-to-consumer ads so consumers can understand a drugs benefi...