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Human Drugs

Cobenfy Effective as Schizophrenia Adjunct: Trial

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

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Human Drugs

Update Drug Labels with Obesity Info: Pitts

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

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Human Drugs

Lilly Sues 4 More Weight-Loss Drug Compounders

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

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Medical Devices

Alert Issued on Conavis Novasight Catheters

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

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Medical Devices

QS Violations at Noah Medical Corporation

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

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Human Drugs

Promising Enhertu+Perjeta Data in Breast Cancer

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

FDA General

Lt. Governors Urge Trump to Support FDA, Other Agencies

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

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Medical Devices

ICU Medical Illegally Marketing Devices: FDA

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

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Federal Register

CDER Continues Quality Management Program

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

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FDA General

FDA Integrity, Decision-Making at Risk: Blog

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