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FDA Prodded to Improve Surrogate Endpoint Transparency

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A Federation of American Scientists online paper says FDA, other federal research agencies, and Congress should take steps to incr...

Taiho Reports Unfavorable DMD Drug Data

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Taiho Pharmaceutical reports disappointing data from its Phase 3 extension study of TAS-205 (pizuglanstat) in patients with Duchen...

FDA Urged to Expand Real-World Data Use

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A bioethicists opinion piece in The Hill says FDA needs to expand its reliance on real-world clinical data to monitor the safety a...

FDA Oxylanthanum Carbonate Complete Response Letter

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FDA issues a complete response letter to Unicycive Therapeutics for its hyperphosphatemia drug oxylanthanum carbonate that cites i...

FDA Accelerated Approval for Dizal Zegfrovy

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FDA gives accelerated approval to Dizals lung cancer drug Zegfrovy, along with a companion diagnostic device.

Staska Multiple Outsourcing Facility Violations

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FDA warns Staska Pharmaceuticals, a Bennett, NE, outsourcing facility, about its multiple failures to meet requirements for such f...

Abiomed Pump Controller Needs Update: FDA

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FDA issues an Early Alert for an Abiomed Automated Impella Controller issue that has resulted in three deaths.

Delayed Hereditary Angioedema Drug Wins Approval

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After delaying a review action last month, FDA now approves a KalVista Pharmaceuticals NDA for Ekterly (sebetralstat) for treating...

FDA Priority Review for Hunter Syndrome Therapy

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FDA accepts for priority review a Denali Therapeutics BLA for tividenofusp alfa for treating Hunter syndrome.

FDA Inspectors Say Conditions Still Hard

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A ProPublica investigative report says FDA inspectors continue to have issues arising from the dismissal of many of their support ...