- A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.
- Merck announced on September 3, 2025, that it is seeking potential approval for new drugs from the FDA.
FDA granted Breakthrough Therapy designation for a drug developed by Merck.
1 report, 1 independent
Updated Aug 18
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What happened
FDA granted Breakthrough Therapy designation for a drug developed by Merck.
Who's involved
What this event is mainly aboutKeep exploring
Part of
Merck announced on September 3, 2025, that it is seeking potential approval for new drugs from the FDA.Also in this story
- Merck is seeking FDA approval for its drug Winrevair, based on data from the ZENITH, HYPERION, and Stellar studies.
- Iovance Biotherapeutics is evaluating its drug Amtagvi with Merck's Keytruda, potentially leading to FDA label expansion.
- Merck's product, Enflonsia, received approval from the FDA in the United States on August 28, 2025.
Within A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.
The entities involved
Related events
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- A product was launched in the U.S. market following FDA involvement.
- FDA approval enables commercial opportunity involving CBRE Group.
- Biocon's subsidiary received FDA approval for a drug in the United States on August 18, 2026.
- MDR/IVDR reforms require adoption by the European Parliament, referencing US FDA pre-submission meetings.
Coverage
Newest first; wire copies grouped- Business WireIfinatamab Deruxtecan Granted Breakthrough Therapy Designation by U.S. FDA for Patients with Pretreated Extensive-Stage Small Cell Lung Cancer Data from IDeate-Lung01 trial will be presented at upcom