Entities / Person
EMA.
Japanese vocalist of the group DUSTCELL
- Reports this week
- 0
- Active events
- 0
- Connections
- 67
What's happening
Reports per dayLast 90 days
90 days agoDrag either end to show only events that began in that periodToday
Earlier this month
One to three months ago
Gone quiet
No new reports in 90+ days-
Eli Lilly and Company is seeking a positive opinion from the EMA regarding the potential indication expansion for its drug, pirtobrutinib.Some support3 reports
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A studio located in East Providence, Rhode Island, meets EMA green seal standards, while Rosa ultimately chose the location over opportunities in Los Angeles.Some support1 report
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The EMA gave a positive opinion for the drug TRYNGOLZA, developed by Ionis Pharmaceuticals, marking a step toward European Commission approval.Some support2 reports
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Zevra Therapeutics submitted a Marketing Authorization Application to the European Medicines Agency for Arimoclomol, targeting Niemann-Pick Disease Type C.Some support4 reports
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FDA approved GAMMAGARD LIQUID ERC for use, while EMA had already approved it as DEQSIGA. The company also benefited from market trends.Some support2 reports
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Certara developed and utilized the Simcyp Simulator platform, which the EMA qualified for regulatory submissions, marking a successful collaboration.Some support1 report
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KalVista Pharmaceuticals received prior regulatory approvals in the UK and the US, and the EMA adopted a positive opinion for its drug sebetralstat, with the EC expected to make a final decision.Some support3 reports1 development inside
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Sanofi received orphan designation from the European Medicines Agency (EMA).Well supported3 reports
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EMA granted Orphan Drug Designation to KRRO-110, a drug candidate from Korro Bio, Inc.Some support2 reports
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Anavex Life Sciences Corp is exploring commercialization efforts in Europe and seeking review for blarcamesine approval from the European Medicines Agency.Some support1 report
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FDA and EMA granted Rare Pediatric Disease and Orphan Drug Designations to Quoin Pharmaceuticals Ltd.Some support1 report
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Bristol Myers Squibb plans to discuss marketing applications with both the FDA and EMA.Well supported3 reports
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The EMA issued a negative opinion on July 25, 2025, recommending the rejection of Sarepta's Elevidys application for European clearance.Some support2 reports
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Rhythm plans Phase III trial design discussions with the FDA and EMA and in-licensed bivamelagon from LG Chem.Some support2 reports
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EMA review led to CE mark certification for FemBloc® on June 25, 2025.Speculative1 report
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FDA approved Ogsiveo and Mirdametinib, while EMA recommended approval for Ogsiveo, for Merck KGaA.Speculative1 report
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GeoVax, led by CEO David Dodd, received SA from EMA for its GEO-MVA and presented at a conference in New York City on September 3, 2025.Some support9 reports
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The FDA and EMA are jointly pushing for the adoption and use of alternative testing assays.Well supported3 reports
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Around EMA this week
News at the entities that move EMA most-
FDA OperationalGeneric medicine services are seeking approval for launch from the FDA.Moves EMA
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Eli Lilly and Company OperationalExxonMobil, Berkshire Hathaway, and Eli Lilly are top holdings in the Avantis ETF.Moves EMA
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DHS is expanding its homeland security portfolio through leadership hires, including an executive with a background in CACI operations.
Moves EMA
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Europe StructuralThe European Central Bank is forced to raise interest rates due to energy price shocks from the Iran war and an influx of Chinese exports.Moves EMA
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Cytokinetics StructuralPrice targets for UDR were adjusted by Cantor Fitzgerald, Scotiabank, and Royal Bank of Canada on May 26, 2026.Moves EMA
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European Commission StructuralA European Commission summit focused on strategic cooperation, minerals, and pivoting away from the United States toward the EU.Moves EMA
Connections
The 14 strongest of 67, analyzed from the reporting. The bars show how strongly a change on one side reaches the other.-
FDA Operational
The agencies actively coordinate regulatory functions, sharing guidance, and influencing each other's drug approval processes.
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Europe Structural
EMA functions as a key regulatory body within the European system, issuing approvals and opinions for clearance.
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European Commission Structural
EMA provides required scientific and regulatory opinions and recommendations that the European Commission must consider before making a final approval decision.
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GeoVax Structural
EMA provides regulatory guidance and scientific advice that influences GeoVax's product development and approval path.
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Cytokinetics Structural
Cytokinetics is actively seeking marketing authorization from the EMA.
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Eli Lilly and Company Operational
EMA actively monitors and provides regulatory opinions on Eli Lilly's drug development and products.
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The individual EMA holds a functional role defined by a specific moniker used by the United States Department of Homeland Security.
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Fayette County Shared context
EMA officials have issued travel warnings regarding Fayette County.
Show all 14 connections
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TenX Structural
The company plans to consult EMA regarding the outcomes of its clinical trials.
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Port of Manzanillo Operational
EMA's regulatory approval processes relate to the Port of Manzanillo's capacity for handling large container vessels.
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Pulaski County Shared context
EMA serves as a director within the jurisdiction of Pulaski County.
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East Providence Shared context
EMA's professional studio operates in East Providence, meeting specific EMA green seal standards.
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Philippines Shared context
An entity associated with EMA is located in the Philippines.
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George W. Bush Mentioned together
No evidence was provided linking EMA and George W. Bush.
History
Events by the month they beganSeptember 2026
1 eventAugust 2026
2 eventsJune 2026
18 events- Eli Lilly and Company is seeking a positive opinion from the EMA regarding the potential indication expansion for its drug, pirtobrutinib.
- A studio located in East Providence, Rhode Island, meets EMA green seal standards, while Rosa ultimately chose the location over opportunities in Los Angeles.
- The EMA gave a positive opinion for the drug TRYNGOLZA, developed by Ionis Pharmaceuticals, marking a step toward European Commission approval.
- Zevra Therapeutics submitted a Marketing Authorization Application to the European Medicines Agency for Arimoclomol, targeting Niemann-Pick Disease Type C.
- FDA approved GAMMAGARD LIQUID ERC for use, while EMA had already approved it as DEQSIGA. The company also benefited from market trends.
- Certara developed and utilized the Simcyp Simulator platform, which the EMA qualified for regulatory submissions, marking a successful collaboration.
- KalVista Pharmaceuticals received prior regulatory approvals in the UK and the US, and the EMA adopted a positive opinion for its drug sebetralstat, with the EC expected to make a final decision.
- Sanofi received orphan designation from the European Medicines Agency (EMA).
- EMA granted Orphan Drug Designation to KRRO-110, a drug candidate from Korro Bio, Inc.
- Anavex Life Sciences Corp is exploring commercialization efforts in Europe and seeking review for blarcamesine approval from the European Medicines Agency.
- FDA and EMA granted Rare Pediatric Disease and Orphan Drug Designations to Quoin Pharmaceuticals Ltd.
- Bristol Myers Squibb plans to discuss marketing applications with both the FDA and EMA.
- The EMA issued a negative opinion on July 25, 2025, recommending the rejection of Sarepta's Elevidys application for European clearance.
- Rhythm plans Phase III trial design discussions with the FDA and EMA and in-licensed bivamelagon from LG Chem.
- EMA review led to CE mark certification for FemBloc® on June 25, 2025.
- FDA approved Ogsiveo and Mirdametinib, while EMA recommended approval for Ogsiveo, for Merck KGaA.
- GeoVax, led by CEO David Dodd, received SA from EMA for its GEO-MVA and presented at a conference in New York City on September 3, 2025.
- The FDA and EMA are jointly pushing for the adoption and use of alternative testing assays.