Meeting Materials NOW Available! – Miltefosine Capsules

Posted by on October 16, 2013

Meeting Materials NOW Available! – Vascepa (icosapent ethyl)

Posted by on October 15, 2013

October 16, 2013 8:00 a.m. to 5:00 p.m.: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee 
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FDA AdComm Roll Call – Who’s New at the FDA?!

Posted by on October 10, 2013

This month we saw the addition of 4 new members to the Anti-infective Drugs Advisory Committee! This committee is now only has 1 vacancy. The new members are:
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Government Shutdown Isn’t Delaying FDA Advisory Meetings

Posted by on October 9, 2013

According to drug and device manufacturers, the US government shutdown which began on October 1, 2013 isn’t preventing the Food and Drug Administration from having their scheduled advisory committee meetings this month.
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Meeting Announcement – Sofosbuvir

Posted by on October 1, 2013

October 25, 2013 8:00 a.m. to 5:00 p.m.: Antiviral Drugs Advisory Committee Meeting Announcement
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Meeting Announcement – Simeprevir

Posted by on October 1, 2013

October 24, 2013 8:00 a.m. to 5:00 p.m.: Antiviral Drugs Advisory Committee Meeting Announcement
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AdComm Roll Call Special – Spotlight on: DSaRM

Posted by on September 25, 2013

The Drug Safety and Risk Management Committee (DSaRM) is a panel composed of FDA appointed members who advise the agency on risk management, risk communication, and quantitative evaluation of spontaneous reports for drugs for human use. 
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FDA Panel Backs Approval of Perjeta for Early-Stage Breast Cancer

Posted by on September 13, 2013

Yesterday, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 13-0, with one abstention, in favor of approving the monoclonal antibody pertuzumab (Perjeta) as an neoadjuvant treatment for HER2-positive, early-stage breast cancer in combination with trastuzumab (Herceptin) and docetaxel (Taxotere) to help shrink tumors prior to surgery in the hope that it will make them easier
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FDA Committee Recommends Approval for Anoro Ellipta

Posted by on September 12, 2013

GlaxoSmithKline PLC and Theravance, Inc. announced today that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted in favor (11 yes, 2 no) that the efficacy and safety data provided substantial evidence to support approval of umeclidinium/vilanterol (UMEC/VI, 62.5/25mcg dose) for the long-term, once-daily, maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD),
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Meeting Materials NOW Available! – PERJETA (pertuzumab) injection

Posted by on September 11, 2013