Meeting Announcement – Vascepa (icosapent ethyl)

Posted by on August 22, 2013

October 16, 2013 8:00 a.m. to 5:00 p.m.: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
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Meeting Announcement – Paladin Therapeutic’s Miltefosine Capsules

Posted by on August 12, 2013

October 18, 2013 8:00 a.m. to 5:00 p.m.: Anti-Infective Drugs Advisory Committee Meeting Announcement 
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Meeting Announcement – PERJETA (pertuzumab) injection

Posted by on August 12, 2013

September 12, 2013 8:00 a.m. to 5:00 p.m.: Oncologic Drugs Advisory Committee Meeting Announcement
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FDA Panel Recommends Riociguat (Adempas) for Pulmonary Hypertension

Posted by on August 9, 2013

The RESULTS are in! On Tuesday, the FDA’s Cardiovascular and Renal Drugs Advisory Committee unanimously recommended Riociguat (Adempas, Bayer Healthcare) as treatment in two forms of pulmonary hypertension; pulmonary arterial hypertension (PAH) of WHO Group 1 and chronic thromboembolic pulmonary hypertension (CTEPH) of WHO Group 4. 
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The Results are In! FDA Panel Vetoes New Tolvaptan Indication

Posted by on August 6, 2013

The Cardiovacular and Renal Drugs Advisory Committee voted 9 – 6 on Monday against endorsing an expanded indication for tolvaptan (Samsca), a product of Otsuka Pharmaceutical Co., Ltd., to treat autosomal dominant polycystic kidney disease (ADPKD). 
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FDA AdComm Roll Call – Check out the 12 New Members of NPDAC!

Posted by on August 6, 2013

This month we saw the departure of 2 members of the Cardiovascular and Renal Drugs Advisory Committee (CRDAC). Both Mr. Allan Coukell and Dr. Rob Scott, an industry Representative from Amgen, have reached the end of their terms in CRDAC. In addition, Dr. Atul Kumar, Dr. Ronald Fogel, and Dr. Garnet Anderson have reached the end
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Meeting Announcement – Glaxo’s NDA for “Anoro Ellipta”

Posted by on August 6, 2013

Meeting Materials NOW Available! – ADEMPAS

Posted by on August 6, 2013

August 6, 2013 8:00 a.m. to 4:00 p.m.: Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting
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Meeting Materials NOW Available! – TOLVAPTAN

Posted by on August 1, 2013

August 5, 2013 8:00 a.m. to 5:30 p.m.: Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement
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FDA Panel Favors Nasacort OTC Switch

Posted by on August 1, 2013

The RESULTS are in!
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