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FDA approves Merck’s ISENTRESS® (raltegravir)
6 January 2012 | By Merck
The U.S. FDA recently approved the use of ISENTRESS® (raltegravir) in combination with other antiretroviral (ARV) medicines...
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Pfizer receives FDA approval to extend use of Prevnar 13®
30 December 2011 | By Pfizer
First pneumococcal conjugate vaccine for adults 50+ has potential to help address high incidence of pneumococcal pneumonia...
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FDA to review potential new use of XGEVA® (Denosumab) at ODAC meeting
29 December 2011 | By Amgen
FDA has invited Amgen to participate in a meeting of the ODAC on Feb. 8, 2012 to discuss the sBLA for XGEVA® (denosumab)...
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Janssen Research & Development submits application to U.S. FDA for XARELTO® (rivaroxaban) to reduce secondary cardiovascular events in patients with ACS
29 December 2011 | By Janssen Research & Development, LLC
Janssen Research & Development, LLC (JRD) have announced that it has submitted a sNDA to the FDA seeking approval for the use of XARELTO® (rivaroxaban)...
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Patient entry completed for Phase III trial programme in Hepatitis C
9 December 2011 | By Boehringer Ingelheim
The final patient has been randomised to treatment in the large-scale Phase III clinical trial programme for BI 201335...
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Abbott receives FDA clearance for new test to detect Vitamin D levels
Abbott announced today it has received clearance from the U.S. Food and Drug Administration for a fully-automated 25-OH Vitamin D assay performed on its widely used ARCHITECT® laboratory testing platform.
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FDA accepts ELIQUIS® (apixaban) New Drug Application for review
29 November 2011 | By Bristol-Myers Squibb Company
Bristol-Myers Squibb Company and Pfizer Inc. announced that the U.S. FDA has accepted for review a NDA for ELIQUIS® (apixaban)...
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NDA for aripiprazole depot formulation for maintenance treatment of adult patients with schizophrenia accepted
22 November 2011 | By H. Lundbeck A/S (Lundbeck)
H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced today that the US Food and Drug Administration (FDA) has determined that a new drug application (NDA) for Otsuka's investigational once-monthly aripiprazole depot formulation for the indication of maintenance treatment of schizophrenia in adults is sufficiently complete to permit…
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FDA Commissioner announces final decision on Avastin for metastatic breast cancer
18 November 2011 | By Roche
FDA Commissioner revokes approval of Avastin for treatment of mBC in the US...
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FDA accepts Roche’s New Drug Application for vismodegib in advanced form of skin cancer
9 November 2011 | By Roche
The vismodegib application has been granted priority review...
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Lilly CEO says appropriate assessment of both benefits and risks critical in regulatory process
2 November 2011 | By Eli Lilly and Company
John Lechleiter calls for balanced decision-making...
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Abbott receives U.S. FDA approval for next-generation XIENCE PRIME™ Drug Eluting Stent
1 November 2011 | By Abbott
FDA approval for the next-generation XIENCE PRIME™ Drug Eluting System...
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US FDA extends action date for dapagliflozin by three months
26 October 2011 | By AstraZeneca
US FDA has extended the action date for dapagliflozin for the treatment of type 2 diabetes by three months...
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FDA approves Onfi™ (clobazam) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome
24 October 2011 | By H. Lundbeck A/S
The FDA has approved Onfi™ (clobazam)...
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Abbott’s genetic test for acute myeloid leukemia prognosis cleared by FDA
24 October 2011 | By Abbott
New test based on FISH technology detects chromosomal abnormality to help predict prognosis of patients with AML...
