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FDA Accepts Exelixis NDA for Metastatic Colorectal Cancer

[ Price : $8.95]

FDA accepts for review an Exelixis NDA for zanzalintinib in combination with the immune checkpoint inhibitor atezolizumab for pati...

Floridas FDA-Authorized Canadian Drug Import Program Stalls

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Floridas FDA-authorized drug importation program stalls and has yet to deliver any imported medicines more than two years after re...

Warning Letter Sent to Beta Bionics

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FDA issues Beta Bionics a Warning Letter following an inspection of the companys Irvine, CA, facility conducted 6/2025.

Complete Response on Pharmings Pediatric sNDA for Joenja

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FDA issues Pharming Group a complete response letter for its supplemental NDA seeking expanded approval of Joenja (leniolisib) for...

FDA Updates Device Inspection Program Due to QMSR Move

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FDA discontinues the use of its Quality System Inspection Technique for medical device inspections and will instead conduct inspec...

Grail Submits Final PMA Module for Cancer Blood Test

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Grail files the final module of its PMA for the companys multi-cancer early detection blood test.

Biogen Breakthrough Status for Lupus Therapy

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FDA awards Biogen a breakthrough therapy designation for its experimental antibody litifilimab for treating cutaneous lupus erythe...

Senators Question HHS Oversight of TrumpRx Platform

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A group of Democratic senators ask HHS Office of Inspector General to clarify how it will oversee direct-to-consumer prescription ...

FDA Releases Corrected Rejection Letter for Corcept NDA

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FDA releases a corrected version of a 12/30 Complete Response Letter issued to Corcept Therapeutics, indicating that the agency ha...

Ultragenyx Resubmits BLA for Gene Therapy

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Ultragenyx Pharmaceutical resubmits a BLA seeking accelerated approval for UX111, an AAV9 gene therapy for the treatment of Sanfil...