Chipotle removes jalapenos linked to Minnesota salmonella outbreak

Celltrion Secures FDA Fast Track Designation for All Three Clinical-Stage ADC Candidates

Celltrion said on Aug. 13 that its antibody-drug conjugate (ADC) candidate CT-P73 has received Fast Track designation from the U.S.

8m ago ·koreaittimes.com

Congo’s Ebola outbreak on track to surpass deadliest in history, WHO chief says

“At its current pace, it’s on track to eclipse the West African Ebola outbreak of 2014 to 2016,” WHO chief Tedros Adhanom Ghebreyesus told reporters on Wednesday.

1h ago ·euronews.com

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.

1h ago ·businesskorea.co.kr

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.

1h ago ·businesskorea.co.kr