However, the time of approval of a drug may not necessarily be equivalent to the time of market authorization—which is a more important time point because it is when a drug becomes available to ...

pre-market authorization of its CARA SYSTEM, a machine-learning-enabled medical device (MLMD). To ensure a smooth regulatory process, DIAGNOS has engaged ORA, a leading clinical research organization ...

Health Canada has granted market authorisation to Takeda Canada for FRUZAQLA (fruquintinib) capsules to treat adults with metastatic colorectal cancer (mCRC). The authorisation is intended for ...

PISCATAWAY, N.J.--(BUSINESS WIRE)--Kashiv BioSciences, LLC (“Kashiv” or the “Company”) today announced that Health Canada has granted marketing authorization for its Pegfilgrastim Injection, enabling ...

and technology-driven solution that improves market access and accelerates patient care." To learn more about how PromptPA can transform your specialty drug prior authorization process ...

which is in addition to the shares remaining available under the company’s existing authorization. Fiserv may repurchase shares in the open market or in privately negotiated transactions at the ...