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NOVAVAX SUBMITS APPLICATION TO THE U.S. FDA FOR EMERGENCY USE AUTHORIZATION FOR NOVAVAX COVID-19 VACCINE,

Novavax, Inc. | August 16, 2022

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Novavax, Inc. a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced that it submitted an application to the U.S. Food and Drug Administration for Emergency Use Authorization of its protein-based COVID-19 Vaccine, Adjuvanted for active immunization to prevent coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 as a homologous and heterologous booster in adults aged 18 a...

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MAYNE PHARMA ANNOUNCES FDA FILING ACCEPTANCE OF NEW DRUG APPLICATION FOR E4/DRSP IN THE US

Mayne Pharma, Mithra | June 24, 2020

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Mayne Pharma Group Limited (ASX: MYX) is pleased to announce the New Drug Application (NDA) for E4/DRSP to prevent pregnancy has been accepted for review by the US Food and Drug Administration (FDA). The FDA is expected to complete its review in the first half of calendar 2021. Developed by Mithra Pharmaceuticals SA (Mithra), E4/DRSP is a novel combined oral contraceptive pill containing 15 mg estetrol (E4) and 3 mg drospirenone (DRSP). E4 is a naturally occurring estrogen that is...

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Pharma Tech

FUSION PHARMACEUTICALS ANNOUNCES PRESENTATION OF PRECLINICAL DATA SUPPORTING ITS FPI-1966 AND FPI-2059 TARGETED ALPHA THERAPIES

Fusion | October 23, 2021

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Fusion Pharmaceuticals a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the presentation of preclinical data that provide further support of its FPI-1966 and FPI-2059 targeted alpha therapies at the 34th Annual European Association of Nuclear Medicine Congress. These data reinforce the clinical dosing regimen of FPI-1966 and highlight the potential of FPI-2059 as an actinium-225 labelled precision medicine target...

Read More

APHA: TRANSPARENCY, SAFETY AND AVAILABILITY MUST BE CORE PRINCIPLES FOR STRENGTHENING AMERICA'S DRUG SUPPLY CHAIN

APhA | August 11, 2020

news image

The reliability, quality and safety of our nation's drug supply chain are essential to the nation's security and health and well-being of the American public. Therefore, we welcome comprehensive federal efforts to improve the state of our drug supply chain, particularly at a time when our health care system is under extraordinary stress. The President's Executive Order last week, "Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United St...

Read More
news image

Business Insights

NOVAVAX SUBMITS APPLICATION TO THE U.S. FDA FOR EMERGENCY USE AUTHORIZATION FOR NOVAVAX COVID-19 VACCINE,

Novavax, Inc. | August 16, 2022

Novavax, Inc. a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced that it submitted an application to the U.S. Food and Drug Administration for Emergency Use Authorization of its protein-based COVID-19 Vaccine, Adjuvanted for active immunization to prevent coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 as a homologous and heterologous booster in adults aged 18 a...

Read More
news image

MAYNE PHARMA ANNOUNCES FDA FILING ACCEPTANCE OF NEW DRUG APPLICATION FOR E4/DRSP IN THE US

Mayne Pharma, Mithra | June 24, 2020

Mayne Pharma Group Limited (ASX: MYX) is pleased to announce the New Drug Application (NDA) for E4/DRSP to prevent pregnancy has been accepted for review by the US Food and Drug Administration (FDA). The FDA is expected to complete its review in the first half of calendar 2021. Developed by Mithra Pharmaceuticals SA (Mithra), E4/DRSP is a novel combined oral contraceptive pill containing 15 mg estetrol (E4) and 3 mg drospirenone (DRSP). E4 is a naturally occurring estrogen that is...

Read More
news image

Pharma Tech

FUSION PHARMACEUTICALS ANNOUNCES PRESENTATION OF PRECLINICAL DATA SUPPORTING ITS FPI-1966 AND FPI-2059 TARGETED ALPHA THERAPIES

Fusion | October 23, 2021

Fusion Pharmaceuticals a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the presentation of preclinical data that provide further support of its FPI-1966 and FPI-2059 targeted alpha therapies at the 34th Annual European Association of Nuclear Medicine Congress. These data reinforce the clinical dosing regimen of FPI-1966 and highlight the potential of FPI-2059 as an actinium-225 labelled precision medicine target...

Read More
news image

APHA: TRANSPARENCY, SAFETY AND AVAILABILITY MUST BE CORE PRINCIPLES FOR STRENGTHENING AMERICA'S DRUG SUPPLY CHAIN

APhA | August 11, 2020

The reliability, quality and safety of our nation's drug supply chain are essential to the nation's security and health and well-being of the American public. Therefore, we welcome comprehensive federal efforts to improve the state of our drug supply chain, particularly at a time when our health care system is under extraordinary stress. The President's Executive Order last week, "Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United St...

Read More