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Lytgobi Web Page False, Misleading: FDA

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The CDER Office of Prescription Drug Promotion cautions Taiho Oncology about misleading efficacy presentations in a Web page for i...

Approvable Letter for Sleep Apnea Device

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FDA sends Nyxoah an approvable letter on its PMA for the Genio system, a neuromodulation device for treating obstructive sleep apn...

Rybrevant Beats Tagrisso in Head-to-Head Trial: J&J

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Johnson & Johnson says Rybrevant outperformed AstraZenecas Tagrisso in a head-to-head study in the first-line treatment of patient...

Covidien Recalls Shiley Tracheostomy Tube

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Covidien recalls its Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula due to safety concerns if...

7 QS Violations in Dexcom Inspection

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FDA warns San Diego-based Dexcom about Quality System violations in its production of unapproved glucose monitors.

API Deviations at Aspen Biopharma Labs

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FDA warns Indias Aspen Biopharma about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

Smiths Medical Recalls Endotracheal Tubes

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Smiths Medical recalls its oral/nasal endotracheal tubes after becoming aware that certain device sizes may have a smaller diamete...

Cassava Says Simufilam Failed in Alzheimers Study

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Cassava Sciences reports topline results from the Phase 3 REFOCUS-ALZ study of simufilam in mild-to-moderate Alzheimers disease, s...

Confirmatory Evidence in Non-Oncologic Rare Diseases

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FDA researchers examine the use of confirmatory evidence with one adequate and well-controlled trial in non-oncologic drug rare di...

FDA Adds New Chief Operating Officer

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FDA selects former consultant Barclay Butler as its deputy commissioner for operations and chief operating officer.