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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...

Report Highlights Study Demographic Representation

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A new FDA report examines the demographic representation of clinical trials supporting the approval of 50 novel drug therapies las...

REMS Requirements Ended for CAR T Cell Therapies

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FDA removes risk evaluation and mitigation strategies requirements for all currently approved CAR T cell therapies, saying the pro...

UCB Positive Data for Epileptic Encephalopathy Drug

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UCB reports positive data from a Phase 3 clinical trial evaluating fenfluramine as an adjunctive treatment for rare epileptic ence...

Appeals Court Backs FDAs Sameness Interpretation

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An appeals court rules for FDA that a clinically superior drug is not the same as a drug that is otherwise the same.

NDA Filed for Nicotine Dependence Drug

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Achieve Life Sciences files an NDA for cytisinicline for treating nicotine dependence as part of smoking cessation in adults.