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Gilead HIV Drug Gets Complete Response Letter

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FDA issues Gilead Sciences a complete response letter on its NDA for lenacapavir, an investigational, long-acting HIV-1 capsid inh...

FDA Warns on 3 Covid-19 Tests

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FDA issues three safety alerts warning users to not use three Covid-19 tests because they could generate false results.

Guide on Patient-Focused Drug Development

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Federal Register notice: FDA makes available a final guidance entitled Patient-Focused Drug Development: Methods To Identify What ...

Lexicon Yanks Diabetes NDA Over Technical Correction

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Lexicon Pharmaceuticals voluntarily withdraws its NDA for sotagliflozin, indicated for reducing the risk of cardiovascular death, ...

FDA Withdrawing Elancos Sulfamethazine

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Federal Register notice: FDA withdraws approval of an Elanco new animal drug application for use of a prolonged-release bolus cont...

OPDP Likely to Target Exhibit Booths: Attorney

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Arnall Golden Gregory partner Alan Minsk predicts that CDER Office of Prescription Drug Promotion staff this year are likely to fo...

Clinical Sites Should Review Own Corrective Actions: FDA

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FDA officials on a bioresearch monitoring Webinar offer good clinical practice recommendations to sponsors and clinical trial site...

FDA Urges Follow-up on Endovascular Aortic Repair

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FDA sends a letter to healthcare professionals that emphasizes the importance of lifelong surveillance of patients with abdominal ...

FDA Extends Skyrizi sBLA Review by 3 Months

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FDA extends by three months its review of an AbbVie supplemental BLA for Skyrizi (risankizumab-rzaa) for treating moderate to seve...

FDA Revises AstraZenecas Evusheld Dosing

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FDA revises an AstraZeneca emergency use authorization for Evusheld (tixagevimab co-packaged with cilgavimab) to increase the init...