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Human Drugs

NIH Ends Lilly Covid Antibody Study

NIH ends enrollment in a clinical trial of a Lilly investigational monoclonal antibody intended to treat hospitalized Covid-19 patients.

Human Drugs

Homeopathic Drug Marketer Can Challenge FDA Policy: Court

The Washington, DC District Court rules that a recent FDA decision to remove a decades-old compliance policy affecting unapproved homeopathic drugs ca...

Human Drugs

CGMP Violations at KVK-Tech

FDA warns KVK-Tech about CGMP violations in its production of finished drugs.

Federal Register

Meeting on Drug Supply Chain Security Act

Federal Register notice: FDA announces a 12/8-9 virtual public meeting entitled The Drug Supply Chain Security Act Pilot Project Program and Enhanced ...

Federal Register

Panel Reviews Spironolactone for Certain Heart Failure Patients

Federal Register notice: FDA announces a 12/16 advisory committee meeting to discuss spironolactone for the proposed treatment of heart failure with p...

Human Drugs

Panel to Discuss Novartis sNDA for Entresto

Federal Register notice: FDA announces a 12/15 advisory committee meeting that will review a Novartis supplemental NDA for Entresto (sacubitril and va...

Human Drugs

FDA Grant to C-Path for Neonate Drug Study

FDA awards a multi-year grant to C-Path to advance standards and methodologies designed to generate real-world evidence from real-world drug data in a...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include KVK-Tech and Shilpa Medicare Limited.

Medical Devices

Abiomeds Cardiopulmonary Bypass Cleared by FDA

FDA grants Abiomed 510(k) clearance for an all-in-one, compact cardiopulmonary bypass system called the Abiomed Breethe OXY-1 System.

Biologics

Covid Travel Ban Blocks Spectrum Cancer Drug Inspection

FDA defers a review action on a Spectrum Pharmaceuticals BLA for Rolontis (eflapegrastim) because of a Covid-19-related travel restriction that preven...