Hemosphere is developing technology based on protein microspheres that have a variety of potential diagnostic and therapeutic biopharmaceutical applications, including synthetic platelets, drug delivery and imaging.
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The Canadian authorities have put in place an expedited pathway for authorizing new COVID-19 drugs and vaccines that offers a more agile approach to reviewing data than what was previously allowed.
The UK medicines regulator has a “unique opportunity” to evaluate the systems it operates and to “do things differently", according to its long-term interim head, June Raine.
No device-related warning letters were released by the US FDA the week of 22 September.