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
Merck and Daiichi successfully advanced an ADC through co-development, gaining Breakthrough Therapy designation from the FDA and orphan drug status in Europe.
Who's involved
What this event is mainly aboutKeep exploring
The entities involved
- FDA
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Merck
public company in Indonesia
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Daiichi
supermarket in Obihiro, Hokkaido, Japan
Nothing else this week.
Related events
- FDA clearance enables market entry into the U.S. for an unnamed company, which is also navigating the long-term regulatory process in Japan.
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- Amylyx Pharmaceuticals is seeking FDA approval for a new drug treatment.
- Merck has set the list price for a drug that received approval from the FDA.
Coverage
Newest first; wire copies grouped- ZacksMRK'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