- 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.
8 reports, 6 independent
Updated Aug 7
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New informationRepeats or wire copies
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What happened
Merck announced on September 3, 2025, that it is seeking potential approval for new drugs from the FDA.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.FDA approved the novel oral cholesterol drug from Merck.1 source
FDA grants approval for Merck's cancer treatments.1 source
- Merck is seeking FDA approval for its drug Winrevair, based on data from the ZENITH, HYPERION, and Stellar studies.Sub-event
- The FDA is reviewing TAR-200 for approval, a process involving major pharmaceutical companies like Merck, AstraZeneca, and Pfizer in the oncology space.Sub-event
- FDA granted Breakthrough Therapy designation for a drug developed by Merck.Sub-event
- Ipsen received regulatory approval for Cabometyx, marking a competitive development with Merck in the renal cell carcinoma space.Sub-event
- Iovance Biotherapeutics is evaluating its drug Amtagvi with Merck's Keytruda, potentially leading to FDA label expansion.Sub-event
- Merck's product, Enflonsia, received approval from the FDA in the United States on August 28, 2025.Sub-event
Show 2 earlier steps
Merck is seeking potential FDA approval for new drugs.1 source
Merck received Breakthrough Designation from the FDA and explored acquisitions of Verona Pharma.1 source
Keep exploring
Part of
A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.Also in this story
- A partnership with BARDA has accelerated the development of SCY-247 for the company.
- A company plans to submit regulatory applications to the FDA, EMA, and Australian TGA.
- Approval leads to procurement process initiation.
- UroGen Pharma Ltd., headquartered in Princeton, is seeking FDA approval for its products for the U.S. market.
The entities involved
Related events
- Merck has set the list price for a drug that received approval from the FDA.
- Amylyx Pharmaceuticals is seeking FDA approval for a new drug treatment.
- The FDA recommended advancement for a new drug application submitted by a company.
- Merck's stock price increased following positive drug performance involving Summit Therapeutics.
- FDA and Pfizer are seeking regulatory approval for their products.
Coverage
Newest first; wire copies grouped- healio.com
- wjla.com
- yahoo.com
- ZacksMRK Posts Cholesterol Drug Data, Focus Shifts Back to Its Pipeline Merck MRK is thriving on new products and pipeline candidates to drive its long-term growth. The company has built a substantial por
- Simply Wall St.Merck (MRK) Antibody Drug Ifinatamab Deruxtecan Gains Breakthrough Therapy Designation Recent advancements in Merck's (MRK) product portfolio, including the FDA's Breakthrough Therapy Designation for
- ZacksFDA Accepts Merck's Filing for Two-Drug, Once-Daily HIV Pill Merck MRK announced that the FDA has accepted for review the new drug application (“NDA”) seeking approval for its investigational, once-d
- Business WireU.S. FDA Accepts New Drug Application for Merck’s Doravirine/Islatravir, an Investigational, Once-Daily, Oral, Two-Drug Regimen for Treatment of Adults with Virologically Suppressed HIV-1 Infection D
- Unknown outlet