Merck and Daiichi successfully advanced an ADC through co-development, gaining Breakthrough Therapy designation from the FDA and orphan drug status in Europe.

1 report, 1 independent Updated Aug 19

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What happened

Some supportReported by 1 outlet

Who's involved

What this event is mainly about

FDA Merck Daiichi

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Part of

Merck and Daiichi began a Phase III study after Merck acquired co-development rights from Daiichi. All 1 developments

The entities involved

FDA
- PAVmed is facing the requirement of regulatory clearance for its company products, while also attracting institutional investment interest.21:51
- The FDA (Q11200607) and the Food Safety and Standards Authority of India (Q5465383) are involved in a new development regarding the governance of inspections.20:44
Merck
public company in Indonesia
- Merck and Moderna funded an Australian-led clinical trial involving the University of Sydney.22:35
- Moderna's therapy combined with Merck's drug in an Australian-led clinical trial.22:35
Daiichi
supermarket in Obihiro, Hokkaido, Japan

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Aug 19ZacksMRK's ADC Candidate Gets FDA Breakthrough Therapy Tag for Lung Cancer Merck MRK announced that the FDA has granted the Breakthrough Therapy designation (BTD) to its B7-H3-directed DXd antibody-drug c