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FDA Approvals

5 FDA Rulings To Keep An Eye On In The 2023 First Quarter

FDA Approvals
The biotechnology sector had a decline in 2022 that went beyond just falling stock prices. Additionally, only 37 new drugs were approved by the...

First Treatment For Advanced ASPS Is Given The Green Light

FDA Approvals
Atezolizumab (Tecentriq), a therapy for advanced alveolar soft tissue sarcoma (ASPS), has received FDA approval for the first time for adults and children two...

FDA Drug Nods In 2022 Fall To 37 From 51 Average Since 2017

FDA Approvals
The FDA recorded only 37 new drug approvals in 2022, down from an annual average of 51 since 2017. After having to retract its...

PAXLOVID, The First Oral COVID-19 Generic, Is WHO-Approved

FDA Approvals
The generic version of the COVID-19 oral antiviral therapy candidate nirmatrelvir has been approved by the World Health Organization Prequalification of Medicines Program (WHO...

First Gene Treatment For Early Bladder Cancer Okayed By FDA

FDA Approvals
The first gene therapy for non-muscle invasive bladder cancer (NMIBC) in individuals with high-risk carcinoma in situ (CIS) with or without papillary tumours has...

Hemophilia Gene Therapy Now Backed By European Regulators

FDA Approvals
The agency that suggests which medications should be allowed in Europe has backed five new ones, including a gene therapy for haemophilia, a combo...

Redesigning The Human Medicines Directive And Regulation

FDA Approvals
What changes are in store for the European Human Medicines Directive and Regulation when it is amended at the end of 2022? The current European...

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The Future of Digital Health

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The pharmaceutical industry is acutely aware that the future of health and care, particularly in the United States, are trending toward a digital revolution....

Five Best Practices to Deliver Exceptional Multichannel Experiences

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A one-size-fits-all customer journey no longer works. In the age of the consumer, the quality of the interaction is paramount. In this paper, we...

The Impact and Use of Social Media in Pharmacovigilance

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Social media presents new channels and methods for biopharmaceutical companies to move away from traditional pharmacovigilance (PV) systems and safety reporting methods towards more...

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