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Panel Rejects Lexicon Pharma Diabetes Drug

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A FDA advisory committee votes against recommending approval for Lexicon Pharmaceuticals' drug Zynquista (sotagliflozin) for adult...

FDA Reconsiders CAR-T Product Warning: Marks

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FDA backpedals on safety warnings it required on CAR-T cell therapies related to secondary cancers, according to CBER director Pet...

Percussionaire Recalls Breathing Circuits

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Percussionaire recalls certain lots of its Phasitron 5 breathing circuits due to the unexpected presence of nickel coating on one ...

Opioid REMS to Require Mail-Back Envelopes

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FDA approves the addition of mail-back envelopes to the existing opioid analgesic risk evaluation and mitigation strategy to help ...

FDA Taps Comstock Rick for Rare Disease Hub

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FDA brings on former Leavitt Partners consultant Amy Comstock Rick to serve as strategic coalitions director for the newly created...

Aarti Drugs India Plant Hit with FDA-483

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A recent inspection of Aarti Drugs Ltds active pharmaceutical ingredient manufacturing plant in India leads to a seven-item FDA Fo...

Sen. Rubio Seeks to Ban Certain APIs from China

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Senator Marco Rubio (R-FL) urges FDA to take immediate action against two pharmaceutical companies based in Chinas Xinjiang region...

Syndax Leukemia Review Extended by FDA

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FDA extends by three months its review of a Syndax Pharmaceuticals NDA for revumenib and its use in treating adult and pediatric p...

NEWSROOM CLOSED FOR THE HOLIDAYS

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FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Tuesday, January 2, 2024.

FDA OKs Merck Kidney Cancer Drug

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FDA approves a Merck NDA for Welireg (belzutifan) for treating patients with advanced kidney cancer following a programmed death r...