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Original New Drug Application Approvals by US FDA (01 - 15 September 2022)

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New drug applications approved by US FDA as of 01 - 15 September 2022 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 May 2022

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New drug applications approved by US FDA as of 16-31 May 2022 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 - 28 February 2022)

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New drug applications approved by US FDA as of 16-28 February 2022 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 (01 - 15 November 2019)

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New drug applications approved by US FDA as of 01 - 15 November 2019 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 June 2018)

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New drug applications approved by US FDA as of 1 - 15 June 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.

The role of oral antivirals in COVID-19 treatment: Who, when, and how?

Dr. Roger Paredes, Dr. Nicola Petrosillo, Dr. Petrick Periyasamy, 30 Jan 2023

Though most countries have eased pandemic restrictions, there is no room for complacency in managing COVID-19, which continues to cause significant morbidity and mortality.

At a recent symposium, esteemed experts Dr Roger Paredes, Head of Department of Infectious Diseases at the Hospital Universitari Germans Trias i Pujol, Badalona, Catalonia, Spain, and Dr Nicola Petrosillo, Head of the Infection Prevention and Control and Infectious Disease Service at University Hospital Campus Bio-Medico, Rome, Italy, gave global perspectives on the continuing unmet needs in the COVID-19 outpatient landscape and discussed the role of antiviral treatment options in patients at risk of progressing to severe COVID-19. Dr Petrick Periyasamy, Head of Infectious Diseases Unit, Medical Department, UKM Medical Centre, Kuala Lumpur, Malaysia, chaired the session.

Product Highlight - XOFLUZA

16 Sep 2020

XOFLUZA – Baloxavir marboxil 20 mg and 40 mg FC tab

Tackling multidrug-resistant gram-negative bacterial infections in critically ill patients: Challenging the standard approach

Dr. Asok Kurup, Dr. Kenneth Chan, 07 Dec 2020

The rising incidence of infections caused by multidrug-resistant (MDR) gram-negative bacteria has become a serious health threat and a major challenge for intensivists. Against a backdrop of high patient mortality and risk factors for infection in intensive care units (ICU), early adequate therapy is of paramount importance. At a recent Pfizer-sponsored symposium, Dr Asok Kurup, Infectious Disease Physician, Singapore presented the implications of MDR gram-negative infections in critically ill patients in Asia, while Dr Kenneth Chan, Respiratory Physician and Intensivist, Singapore highlighted the role of ceftazidime-avibactam (Zavicefta) and shared published real-world data on ceftazidime-avibactam.