The FDA has granted Breakthrough Therapy Designation to Roche (OTCQX:RHHBY) unit Genentech’s Esbriet (pirfenidone) for adults with unclassifiable interstitial lung disease (uILD).
Breakthrough Therapy status provides for more
intensive guidance from the FDA on development, the involvement of more
senior agency personnel and a rolling review of the marketing
application.
https://seekingalpha.com/news/3547893-genentech-s-esbriet-breakthrough-therapy-for-interstitial-lung-disease
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