Keeping Track: US FDA Clears Santen’s Omlonti, Fennec’s Pedmark; Lilly’s Retevmo Adds Tumor-Agnostic Claim
The latest drug approval news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Coherus Biosimilar Used ‘Scientific Justification’ To Skip Switch Study, Still Get Interchangeability With Lucentis
Information on mechanism of action, pharmacokinetics, immunogenicity and toxicity convinced the US FDA there was no risk in terms of safety or diminished efficacy of switching between Cimerli and the reference product, Genentech’s eye drug Lucentis.
CEO of Japanese ophthalmology specialist lays out clear-sighted business vision as track laid for expansion into global markets and new indications amid expiry challenges at home. New modalities are also being explored to meet needs in demanding disorders, Shigeo Taniuchi tells Scrip in an exclusive interview.