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Sirtex Medical Wins Device OK for Liver Cancer

[ Price : $8.95]

FDA approves a Sirtex Medical PMA for its SIR-Spheres Y-90 resin microspheres for treating unresectable hepatocellular carcinoma.

Vacate RFK Jr. Covid Vaccine Recommendations: Lawsuit

[ Price : $8.95]

A group of medical societies files suit against HHS secretary Robert F. Kennedy Jr. and FDA commissioner Marty Makary to reverse a...

FDA Oxylanthanum Carbonate Complete Response Letter

[ Price : $8.95]

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

FDA Accelerated Approval for Dizal Zegfrovy

[ Price : $8.95]

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 ...

FDA WEBVIEW CLOSED JULY 4TH WEEK

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In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Mo...