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Human Drugs

Appeals Court Nixes Sandoz Generic Aubagio Suit

The DC Circuit Court of Appeals says Sanofi was entitled to new chemical entity exclusivity for its Aubagio and Sandoz is not entitled to exclusivity ...

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Human Drugs

Negative Controls and Real-World Evidence Workshop

FDA announces a 3/8 workshop entitled Understanding the Use of Negative Controls to Assess the Validity of Non-Interventional Studies of Treatment Usi...

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Medical Devices

Abbotts Navitor Approved for Aortic Stenosis

FDA approves Abbotts latest-generation transcatheter aortic valve implantation system, Navitor, for treating people with severe aortic stenosis.

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Human Drugs

Sterile Drug Issues at Optum Infusion

FDA warns Chandler, AZ-based Optum Infusion Services about adulterated sterile drug products.

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Human Drugs

FDA Expands CN Bio Collaboration

FDA expands its collaboration with CN Bio, adding research investigating the use of multi-organ microphysiological systems in estimating human drug bi...

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FDA General

Diagnostics, Dietary Supplement Reforms on FDA Legislative Agenda

FDA deputy commissioner for policy, legislation and international affairs Andi Fristedt says her office continues to have its sights on urging Congres...

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Human Drugs

Guide Seeks Dose Optimization in Cancer Drug Development

FDA posts a draft guidance entitled Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases....

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Biologics

Texas Court Grants FDA Win in Vaccine EUAs

A Texas federal court sides with FDA in a lawsuit opposing the Covid-19 vaccines emergency use authorizations for use in children.

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Human Drugs

AstraZeneca Discontinuing Lumoxiti for Hairy Cell Leukemia

AstraZeneca says it is permanently discontinuing sales of Lumoxiti (moxetumomab pasudotox-tdfk) for injection, indicated for treating adults with rela...

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Biologics

FDA/CDC Dismiss Signal with Pfizer Bivalent Vaccine

FDA and CDC dismiss a recent potential safety signal suggesting Pfizers bivalent Covid-19 vaccine may cause ischemic stroke in people aged 65 and olde...