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Original New Drug Application Approvals by US FDA (01 - 15 November 2018)

20181115000000

New drug applications approved by US FDA as of 01 - 15 November 2018 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Original New Drug Application Approvals by US FDA (16 - 31 October 2018)

20181031000000

New drug applications approved by US FDA as of 16 - 31 October 2018 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Original New Drug Application Approvals by US FDA (1 - 15 October 2018)

20181015000000

New drug applications approved by US FDA as of 1 - 15 October 2018 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Original New Drug Application Approvals by US FDA (15 - 30 September 2018)

20180930000000

New drug applications approved by US FDA as of 15 - 30 September 2018 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Product Highlight-Praluent

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PRALUENT – alirocumab 75 mg/mL and 150 mg/mL soln for inj - sanofi-aventis

Product Highlight-Victoza

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VICTOZA – Liraglutide 6 mg/mL soln for inj - Novo Nordisk

Product Highlight-Skycellflu

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SKYCELLFLU – Inactivated quadrivalent influenza vaccine (inj) 0.5 mL - AJ Biologics

Original New Drug Application Approvals by US FDA (1 - 15 September 2018)

20180915000000

New drug applications approved by US FDA as of 1 - 15 September 2018 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Original New Drug Application Approvals by US FDA (16 - 31 August 2018)

20180831000000

New drug applications approved by US FDA as of 16 - 31 August 2018 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Original New Drug Application Approvals by US FDA (1 - 15 August 2018)

20180815000000

New drug applications approved by US FDA as of 01 - 15 August 2018 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

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New ESC guidelines zero in on lipids, diabetes, and more

Elvira Manzano, Roshini Claire Anthony, 01 Oct 2019

The European Society of Cardiology (ESC) has released five new guidelines at the ESC Congress 2019, recommending an even lower LDL-C* target in patients at very high risk for cardiovascular disease (CVD), and the use of SGLT2** inhibitors and GLP-1*** receptor agonists as first-line treatments in those with diabetes to reduce their CVD risk.

Limited benefit to extending letrozole therapy in postmenopausal breast cancer patients

Roshini Claire Anthony, 16 Dec 2016

Five years of extended therapy with the aromatase inhibitor (AI) letrozole did not improve survival in postmenopausal breast cancer patients, according to findings of the NRG Oncology/NSABP B-42 trial presented at the San Antonio Breast Cancer Symposium (SABCS 2016) held in Texas, US.

Everolimus/fulvestrant combination improves PFS in HR-positive breast cancer

Jackey Suen, 21 Dec 2016

Adding everolimus to fulvestrant in second-line treatment of hormone receptor (HR)-positive, HER2-negative advanced breast cancer improves progression-free survival (PFS) by 40 percent, the phase II PrECOG 0102 study has shown. [SABCS 2016, abstract S1-02]