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WHO warns of a record-breaking Ebola outbreak in the Congo

Geneva: The World Health Organization (WHO) has said that the current Ebola outbreak in the Democratic Republic of the Congo could reach unprecedented proportions. The epidemic in...

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Celltrion ADC Candidates Win FDA Fast Track

All three antibody-drug conjugate (ADC)-based anticancer new drug candidates being developed by Celltrion have been named targets for the Fast Track designation by the U.S.

  • Celltrion secures FDA Fast Track designation for three ADC candidates.
  • CT-P73 targets recurrent and metastatic cervical cancer.
  • Designation aims to expedite development and commercialization.

Novo Nordisk FDA Setback Creates Opportunity for Korean CDMOs

Denmark’s Novo Nordisk, which has led the global pharmaceutical and biotech market on the back of explosive demand for the obesity treatments Wegovy and Ozempic, has run into an unexpected hurdle as…

  • FDA withholds approval for Novo Nordisk facilities due to quality-control violations.
  • Novo Nordisk's Bloomington facility received critical observations, including sterility failures.
  • Korean CDMOs like Celltrion and Samsung Biologics benefit from regulatory challenges.