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CMC: Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)

Friday, June 26, 2026 at 5:01 PM ET
$CMC
CMC: Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)

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Jun 26, 8:00 PM

Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)

STOCKHOLM, June 26, 2026 /PRNewswire/ --The FDA has requested additional data related to chemistry, manufacturing, and controls (CMC) and contract manufacturing facilities; no clinical safety or efficacy concerns were identified that impact approvability Sobi to meet with FDA to discuss...

Source: PR Newswire
Jun 26, 7:59 PM

Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)

STOCKHOLM, June 26, 2026 /PRNewswire/ --The FDA has requested additional data related to chemistry, manufacturing, and controls (CMC) and contract manufacturing facilities; no clinical safety or efficacy concerns were identified that impact approvability Sobi to meet with FDA to discuss...

Source: PR Newswire

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