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Simplified Dosing for Cumberlands Acetadote OKd

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FDA approves a Cumberland Pharmaceuticals supplemental NDA for a simplified dosing regimen of its Acetadote (N-acetylcysteine for ...

Mixed Results on Keytruda Ovarian Cancer Study

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Merck says a Phase 3 KEYLYNK-001 trial evaluating Keytruda (pembrolizumab) plus chemotherapy followed by maintenance with Lynparza...

Agios Seeks Expanded Use for Pyrukynd

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Agios files a supplemental NDA for an expanded indication for its Pyrukynd (mitapivat) for treating adult patients with alpha- or ...

FDA Clears Prostate Tissue Ablator

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FDA clears an AngioDynamics 510(k) for the NanoKnife System for prostate tissue ablation.

AbbVie Reports Positive Parkinsons Trial Data

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AbbVie announces positive topline results from its pivotal Phase 3 TEMPO-2 trial evaluating tavapadon as an early Parkinson's dise...

Chimerix Plans Accelerated Approval NDA for Gliomas Drug

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Chimerix plans to submit an NDA before the end of the year seeking accelerated approval for dordaviprone for treating recurrent H3...

Fresenius Hit With 11-Item FDA-483

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FDA releases an 11-item Form FDA-483 from a 10/2023 Fresenius Kabi Oncology inspection at the companys Pradesh, India manufacturin...

e-Submission Guide for BIMO Inspection Planning

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FDA posts a final guidance entitled Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Biore...

Panel to Discuss Opioid Abuse Studies

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Federal Register notice: FDA announces a 2/5 joint meeting of its Drug Safety and Risk Management Advisory Committee and Anestheti...

Drug/Biologic Accelerated Approval Draft Guide

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Federal Register notice: FDA makes available a draft guidance entitled Expedited Program for Serious Conditions Accelerated Appro...