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Biologics

Alvotech Inspection Findings Hold Up Humira Biosimilar

FDA sends Alvotech a complete response letter on its proposed Humira biosimilar AVT02, citing inspection deficiencies at its Reykjavik, Iceland manufa...

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Human Drugs

FDA Denies Most of Salix Xifaxin Petition

FDA denies most requests in a Salix Pharmaceuticals petition asking for restrictions on approval of ANDAs citing its Xifaxin as the reference-listed d...

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Bayer Paying $40 Million to Settle 2 Whistleblower Suits

Bayer agrees to pay $40 million to the federal government and 20 states to resolve two whistleblower False Claims Act suits over three of its drugs.

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FDA General

Advancing Regulatory Science at FDA 2022 Report

FDA releases its 2022 report on advancing regulatory science with updates to the focus areas identified in the 2021 regulatory science report.

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Human Drugs

Bausch & Lomb/Novaliq NDA for Dry Eye Disease

FDA accepts for review a Bausch & Lomb and Novaliq NDA for NOV03 (perfluorohexyloctane), an eye drop therapy for treating the signs and symptoms of dr...

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Medical Devices

Magnus Medical Neurostimulation for Depression Cleared

FDA clears a Magnus Medical 510(k) for the Saint Neuromodulation System for treating major depressive disorder in adults who have failed to achieve sa...

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Federal Register

BioMarin Wins Priority Review Voucher

Federal Register notice: FDA announces the issuance of a priority review voucher to BioMarin Pharmaceutical for a rare pediatric disease product appli...

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Human Drugs

FDA Approves Boehringer Pustular Psoriasis Drug

FDA approves a Boehringer Ingelheim NDA for Spevigo (spesolimab) as a treatment option for generalized pustular psoriasis flares in adults.

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Federal Register

Panel to Review Glaxo Kidney Disease Anemia Drug

Federal Register notice: FDA advisory committee reviews GlaxoSmithKline NDA for daprodustat, indicated for treating anemia due to chronic kidney disea...

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Human Drugs

Azurity's Konvomep Approved for Gastric Ulcers

FDA approves an Azurity Pharmaceuticals NDA for Konvomep (omeprazole and sodium bicarbonate for oral suspension), a proton pump inhibitor for treating...