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China API Supply Disruption Over Coronavirus: Survey

[ Price : $8.95]

A survey of China-based active pharmaceutical ingredient makers and worldwide users indicates that suppliers may experience some d...

Genus Lifesciences Asks Court to Toss Lannett Drug Approval

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Genus Lifesciences asks the DC federal court to rule that FDA unlawfully approved Lannetts Numbrino during a time when Genus had N...

Wave Miami Distributing Unapproved New Drug: FDA

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FDA warns Wave Miami that it is distributing an unapproved and misbranded new drug containing an undeclared erectile dysfunction d...

FDA Launches Interactive PEPFAR Database

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FDA launches a mobile-friendly database with information, including labeling, on antiretroviral drugs approved for use in the PEPF...

Novartis Walks Away from Generic Advair

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Novartis says it is abandoning its development program for a generic copy of GlaxoSmithKlines Advair Diskus (fluticasone propionat...

Sony Operating Room Imaging Platform Cleared

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FDA clears a Sony Electronics 510(k) for its Nucleus Operating Room Imaging Management and Collaboration Control platform.

Court Denies FDA Move Against California Stem Cell Clinics

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A California federal judge says an FDA suit against two California stem cell clinics should go to trial to determine whether the a...

Study Supports GCSF Use in Treating Strokes

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A study from Florida Atlantic Universitys Schmidt College of Medicine finds that granulocyte colony-stimulating factor or Amgens N...

Study on Oncology DTC Advertising

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Federal Register notice: FDA sends to OMB a proposed Study of Oncology Indications in Direct-to-Consumer Television Advertising.

CGMP Violations at Sunstar Guangzhou

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FDA warns Chinas Sunstar Guangzhou about CGMP violations in its production of finished drugs.