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Latest From Advanced Accelerator Applications SA
FDA Is ‘Getting More Aggressive’ In Going After Drug Efficacy Claims Outside Label
Regulatory experts note there has been an uptick in enforcement letters objecting to efficacy presentations in Rx drug promotions that are not consistent with FDA-required labeling. Panelists at FDLI meeting also discuss the use of real-world evidence in prescription drug promotion.
Big Pharma Companies Have Higher US FDA Approval Percentage Than Everybody Else
Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a recent analysis of FDA approval decisions since 2021.
Big Pharma Companies Have Higher US FDA Approval Percentage Than Everybody Else
Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a Pink Sheet analysis of FDA approval decisions since 2021.
Why Novartis Rejected Access Consortium In Favor Of Direct UK Radioligand Filing
A direct marketing authorization application to the UK medicines regulator offered a quicker route to approval for Novartis’ prostate cancer treatment Pluvicto than following the international Access Consortium process, because of the novel nature of the therapy, according to the company.
Company Information
- Industry
- Biotechnology
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Pharmaceuticals
- Radiopharmaceuticals, Contrast Agents
- Other Names / Subsidiaries
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- BioSynthema, Inc.
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