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Cobenfy Effective as Schizophrenia Adjunct: Trial

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Bristol Myers Squib says its Cobenfy showed positive results in the Phase 3 ARISE trial as an adjunctive therapy to atypical antip...

Update Drug Labels with Obesity Info: Pitts

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Former FDA associate commissioner Peter Pitts calls on the agency to revise drug labels with obesity safety and effectiveness info...

Lilly Sues 4 More Weight-Loss Drug Compounders

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Lilly sues four additional drug compounders for illegally selling copies of its weight loss and diabetes drugs.

Alert Issued on Conavis Novasight Catheters

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The catheter is part of a system intended for intravascular imaging of coronary arteries.

QS Violations at Noah Medical Corporation

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FDA warns San Jose, CA-based Noah Medical about Quality System violations in its manufacturing of the Galaxy System bronchoscopes ...

Promising Enhertu+Perjeta Data in Breast Cancer

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AstraZeneca and Daiichi Sankyo report interim data from a Phase 3 trial that showed Enhertu (trastuzumab deruxtecan), in combinati...

Lt. Governors Urge Trump to Support FDA, Other Agencies

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The Democratic Lieutenant Governors Association writes president Donald Trump urging him to support and safeguard the integrity of...

ICU Medical Illegally Marketing Devices: FDA

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FDA warns ICU Medical that its Minneapolis, MN-based Smiths Medical ASD unit is illegally marketing adulterated and misbranded inf...

CDER Continues Quality Management Program

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Federal Register notice: FDA seeks drug manufacturing establishments to participate in the second year of its voluntary Quality Ma...

FDA Integrity, Decision-Making at Risk: Blog

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FDA Matters founder Steven Grossman says FDA commissioner Martin Makary and the Trump administration are at a crossroads and need ...