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Category | Regulatory Affairs

Ubichem Approved for cGMP Radiolabelled API Production

Posted on 31 May 2010

Ubichem, a leading provider of chemistry services to the drug development sector, through its Hungarian

Consumers Advised Not to Use Arrow Brand Medicated Oil & – Embrocation

Posted on 27 May 2010

The U.S. Food and Drug Administration today warned consumers not to purchase or use a product called

FDA Launches Initiative to Reduce Infusion Pump Risks

Posted on 23 April 2010

The U.S. Food and Drug Administration today announced a new initiative to address safety problems associated with external infusion pumps, which are

FDA Approval of Asclera Injection

Posted on 23 April 2010

“Spider and reticular veins are a common, often embarrassing condition that can be treated safely and

Genentech Submits Supplemental Application to FDA for Herceptin in Advanced HER2-Positive Stomach Cancer

Posted on 22 April 2010

April 22, 2010 – Genentech, Inc., a wholly owned member of the Roche Group, announced today that the company submitted a supplemental Biologics License Application

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FDA Approves Tarceva as a Maintenance Therapy for Advanced Non-Small Cell Lung Cancer

Posted on 16 April 2010

Genentech, Inc., a wholly owned member of the Roche Group, announced today that the U.S. Food and Drug

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European Medicines Agency Grants to ADIENNE Pharma & Biotech the exclusive Marketing Authorization for the Orphan Drug TEPADINA®

Posted on 18 March 2010

ADIENNE Pharma & Biotech and RIEMSER Arzneimittel AG announce today that the European Medicines Agency (EMA) has granted

FDA Approves Rituxan Plus Chemotherapy for the Most Common Type of Adult Leukemia

Posted on 18 February 2010

Genentech, Inc., a wholly owned member of the Roche Group, and Biogen Idec announced today the U.S. Food and Drug Administration (FDA)

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FDA Clears TransOral Robotic Surgery Developed at Penn

Posted on 04 January 2010

A minimally invasive surgical approach developed by head and neck surgeons at the University of Pennsylvania School of Medicine has been cleared by the U.S. Food and Drug Administration (FDA).

U.S. Court of Appeals (CAFC) Rejects Third Wave/Hologic’s Anti-Trust Claims against QIAGEN

Posted on 01 April 2009

April 1, 2009 – QIAGEN Gaithersburg Inc. (formerly Digene Corporation), a wholly-owned subsidiary of QIAGEN N.V. (NASDAQ: QGEN) today announced the U.S. Court of Appeals

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