These press releases are for business and financial media.
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- Press release archive 2010
- 09 February 2010
- US FDA Approves New Indication for Crestor (Rosuvastatin Calcium) AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved CRESTOR (rosuvastatin calcium) to reduce the risk of stroke, myocardial infarction (heart attack) and arterial revascularization procedures in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease (CVD).
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- Press release archive 2010
- 09 February 2010
- US FDA Approves New Indication for Crestor (Rosuvastatin Calcium) AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved CRESTOR (rosuvastatin calcium) to reduce the risk of stroke, myocardial infarction (heart attack) and arterial revascularization procedures in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease (CVD).
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- Press release archive 2010
- 28 January 2010
- AstraZeneca PLC Fourth Quarter and Full Year Results 2009 AstraZeneca delivered a strong financial performance, exceeding the targets set at the beginning of the year. In addition, good progress was made on the pipeline; with five products awaiting regulatory approval, and four significant late stage development projects through our externalisation efforts added. Revenue in the fourth quarter increased by 4 percent at CER, but was up 9 percent on an actual basis as a result of the positive impact of exchange rate movements.
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- Press release archive 2010
- 07 January 2010
- AstraZeneca Reaches Agreements With Teva Pharmaceuticals Regarding Nexium And Prilosec US Patent Litigations AstraZeneca announced today that it has entered into an agreement with Teva Pharmaceutical Industries Ltd. and affiliates (collectively “Teva”) to settle patent litigation regarding Teva’s proposed generic version of AstraZeneca’s Nexium delayed-release capsules (esomeprazole magnesium)
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- Press release archive 2009
- 24 December 2009
- MedImmune Replies to FDA Complete Response Letter on Motavizumab AstraZeneca today announced that MedImmune, its biologics unit, has filed its formal regulatory reply to a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA). MedImmune received the CRL asking for additional information regarding motavizumab on 25 November 2008, and the company has been in ongoing discussions with FDA reviewers since then to complete and file its CRL reply.
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- Press release archive 2009
- 23 December 2009
- AstraZeneca To Acquire Infection Research Company Novexel And Expand Collaboration With Forest Laboratories AstraZeneca announced today that it has entered into an agreement to acquire Novexel and will collaborate with Forest Laboratories on the future co-development and commercialization of two late-stage antibiotic development programmes.
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- Press release archive 2009
- 15 December 2009
- Favourable Vote From FDA Advisory Committee On Benefit/Risk Of CRESTOR In JUPITER Study Favourable Vote From FDA Advisory Committee On Benefit/Risk Of CRESTOR In JUPITER Study
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- Press release archive 2009
- 11 December 2009
- Advisory Committee Briefing Materials For Crestor sNDA Available On US FDA Web Site The U.S. Food and Drug Administration (FDA) today posted briefing materials in advance of 15 December 2009 Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) to discuss the supplemental New Drug Application (sNDA) filed by AstraZeneca. The briefing materials can be found on the FDA web site.
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- Press release archive 2009
- 04 December 2009
- US FDA Approves Seroquel XR For Add-On Treatment Of Major Depressive Disorder AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR (quetiapine fumarate) Extended Release Tablets as adjunctive (add-on) treatment to antidepressants in adults with Major Depressive Disorder (MDD). SEROQUEL XR is the only medication in its class approved by the FDA to treat both major depressive disorder as adjunctive therapy and acute depressive episodes associated with bipolar disorder as monotherapy.
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- Press release archive 2009
- 04 December 2009
- US FDA Approves Seroquel For The Paediatric Treatment Of Schizophrenia And Bipolar Mania AstraZeneca today announced that the US Food and Drug Administration (FDA) approved SEROQUEL (quetiapine fumarate) Tablets for the treatment of schizophrenia in adolescents (13-17 years of age) as monotherapy, and for the acute treatment of manic episodes associated with bipolar I disorder in children and adolescents (10-17 years of age), both as monotherapy and as an adjunct to lithium or divalproex.
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28.34 GBP - New York
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43.13 USD - Stockholm
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326.80 SEK
At 09-Feb-2010 11:36 GMT
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