CRS | CERES Regulatory Services

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Welcome to our CERES Regulatory Services scheduling page. Every case is unique and personal, so let’s talk. This meeting will be conducted with a Senior Regulatory Consultancy Experts.

Fastest FDA Approvals

Product: BLINCYTO®(blinatumomab)
Year Approved: 2014
FDA Designation: Breakthrough therapy
Months to Approval: 2.5
Product: ICLUSIG® (ponatinib)
Year Approved: 2012
FDA Designation: Priority review
Months to Approval: 2.6
Product: JEVTANA® (cabazitaxel)
Year Approved: 2010
FDA Designation: Priority review
Months to Approval: 2.6
Product: SPINRAZA® (nusinersen)
Year Approved: 2016
FDA Designation: Priority review
Months to Approval: 3
Product: ALECENSA® (alectinib)
Year Approved: 2015
FDA Designation: Priority review
Months to Approval: 3.1
Product: TRIKAFTA™ (elexacaftor/tezacaftor/ivacaftor)
Year Approved: 2019
FDA Designation: Breakthrough therapy
Months to Approval: 3.1
Product: XTANDI® (enzalutamide)
Year Approved: 2012
FDA Designation: Priority review
Months to Approval: 3.3
Product: KALYDECO® (ivacaftor)
Year Approved: 2012
FDA Designation: Priority review
Months to Approval: 3.5
Product: ZELBORAF® (vemurafenib)
Year Approved: 2011
FDA Designation: Priority review
Months to Approval: 3.6
Product: ENHERTU® (fam-trastuzumab deruxtecan-nxki)
Year Approved: 2019
FDA Designation: Breakthrough therapy
Months to Approval: 3.7
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