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Dupixent Filing for Eosinophilic Esophagitis Next Year

[ Price : $8.95]

Regeneron Pharmaceuticals and Sanofi say they will seek FDA approval next year for Dupixent (dupilumab) and its use in treating ch...

Draft Guide on ANDA Facility Inspection Readiness

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Federal Register notice: FDA makes available a draft guidance entitled Facility Readiness: Goal Date Decisions Under GDUFA.

FDA Rejects Supernus NDA for Parkinsons Drug

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FDA sends Supernus Pharmaceuticals a complete response letter on its NDA for SPN-830 (apomorphine) infusion device for the continu...

Data Backs Pulmonary Hypertension Drug: Merck

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Merck reports positive top-line results from a pivotal Phase 3 trial (STELLAR) evaluating the safety and efficacy of sotatercept, ...

Priority Review Voucher Fee Rate Set

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Federal Register notice: FDA announces the fee rate for using a priority review voucher for fiscal year 2023.

Guides on Device Surveillance/Post-approval Studies

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Federal Register notice: FDA makes available final guidances on postmarket surveillance and post-approval study orders.

scPharmaceuticals Gets Heart Failure Drug Approved

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FDA approves scPharmaceuticals Furoscix (furosemide injection) for treating congestion due to fluid overload in adults with New Yo...

FDA Clears Zeiss Medicals Bipolar Forceps

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Zeiss Medical Technology gains 510(k) clearance for MTLawton, disposable bipolar forceps made from a copper-base alloy.

FDA Clears Copan Diagnostics Colibr

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FDA clears a Copan Diagnostics 510(k) for its Colibr, a semi-automated pre-analytical processor that is part of the companys WASPL...

Miscarriage Management Needed on Mifeprex Label: Petititon

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The American College of Obstetricians and Gynecologists and 48 other reproductive health organizations petition FDA to ask Danco L...