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FDA Expands ER-Stimulant Labeling for Weight Loss

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FDA orders Limitation of Use wording in labeling for extended-release stimulants used to treat ADHD to raise the risk of weight lo...

Guidance on Aluminum Content in Parenteral Drugs

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FDA issues a draft guidance entitled Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Al...

FDA Elsa Rollout a Nuanced Dance: Consultant

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Consultant Erika Roberts says FDAs rollout of its staff AI tool Elsa is a good first step, but much more needs to be done to reach...

Sirtex Medical Wins Device OK for Liver Cancer

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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

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

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.