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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...

Atmo Bios Gut Capsule Cleared by FDA

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FDA clears an Atmo Biosciences 510(k) for the ingestible Atmo Gas Capsule System for assessing both whole and regional gut transit...

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.

Livmarli, Bylvay Get Liver Injury/Bleeding Updates

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FDA issues safety-related labeling updates for two bile acid transport inhibitors Mirum Pharmaceuticals Livmarli and Ipsen Biopha...

Antibacterial Therapies Development Q&A Guidance

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FDA publishes a question-and-answer guidance to help sponsors develop new antibacterial drugs.

Altimmune Mixed Results for Pemvidutide in MASH

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Altimmune reports mixed topline results today from its Phase 2b IMPACT trial evaluating pemvidutide in patients with metabolic dys...