Trump’s FDA Cuts Are Putting Drug Development at Risk
New SEC filings from pharmaceutical companies reveal Donald Trump and Elon Musk’s cost-cutting measures could slow drug ...
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FDA accepts Sobi’s Gamifant application for HLH/MAS treatment
The application, which seeks approval for use in both adult and paediatric individuals who show an insufficient response or are not tolerant to glucocorticoids, or with recurrent MAS, has received ...
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FDA ‘breakthrough’ status – a new tool for building oncology brands?
The FDA's new Breakthrough Therapy designation ... One company is already using breakthrough therapy status application itself as positive PR: Novartis boldly announced on May 6th of this year ...
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FDA grants fast track status to Rznomics’ RZ-001 for HCC
The US Food and Drug Administration (FDA ... a rolling review during the biologics licence application phase. In addition to its fast track status for HCC, RZ-001 has been approved for ...
Regeneron: FDA Accepts Odronextamab Lymphoma Drug Resubmission
Regeneron last year won European Commission approval of odronextamab as Ordspono for relapsed/refractory follicular lymphoma or diffuse large B-cell lymphoma after two or more lines of systemic ...