The company said it received notice on January 1 from the FDA’s Center for Veterinary Medicine that the funding will support its ongoing effectiveness study of Canalevia-CA1
The decision positions Yartemlea as the first and only approved inhibitor of the lectin pathway of complement
Our scientists found that toxicological data for most PFAS are incomplete or unavailable, leaving significant uncertainty about consumer safety
The filing clears the regulatory path for potential first-in-human trials and marks a key advance in the company’s chronic inflammatory disease pipeline
The approval is supported by data from three pivotal clinical trials
The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer
Tolebrutinib had been provisionally approved in the United Arab Emirates in July 2025 for nrSPMS to slow disability accumulation independent of relapse activity
These observations are procedural in nature and the company does not anticipate any impact on supply of its commercial products
This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care
NUFYMCO BLA has been approved by the USFDA
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