Entities / Person
EMA.
Japanese vocalist of the group DUSTCELL
- Reports this week
- 0
- Active events
- 1
- Connections
- 69
What's happening
Reports per dayLast 90 days
90 days agoDrag either end to show only events that began in that periodToday
Active this week
Earlier this month
One to three months ago
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Homeland Security attached moniker to EMA, while Bush established NIMS through Homeland Security offices across Ohio.Some support1 report
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EMA has been appointed as the director in Pulaski County.Some support1 report
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TenX plans to consult both the FDA and EMA regarding the results of its clinical trials.Some support1 report
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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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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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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EMA granted Orphan Drug Designation to KRRO-110, a drug candidate from Korro Bio, Inc.Some support2 reports
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Sanofi received orphan designation from the European Medicines Agency (EMA).Well supported3 reports
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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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FDA and EMA granted Rare Pediatric Disease and Orphan Drug Designations to Quoin Pharmaceuticals Ltd.Some support1 report
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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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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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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
No events began in the chosen period. Widen it, or reset.
Around EMA this week
News at the entities that move EMA most-
FDA OperationalFDA conducted surprise raids and inspections in Bihar state, directed by state government officials.Moves EMA
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Eli Lilly and Company OperationalEli Lilly and Merck are combining therapies in clinical trials.Moves EMA
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The Trump administration highlighted arrests made by Homeland Security, mentioning Syracuse resident Cook.
Moves EMA
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Europe StructuralThe pandemic originated in India and subsequently spread westward.Moves EMA
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European Commission StructuralMureșan supports the EU's global vision as the Commission centers the bloc in Brussels amid Canada's geopolitical shift.Moves EMA
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Cytokinetics StructuralSung Lee became EVP at Cytokinetics, and Bank of Montreal increased its holdings in the company.Moves EMA
Connections
The 14 strongest of 69, 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 opinions and recommendations that the European Commission must consider for final approval.
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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 beganOctober 2026
2 eventsSeptember 2026
1 eventAugust 2026
2 eventsShow 1 earlier month
June 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.
- FDA approved GAMMAGARD LIQUID ERC for use, while EMA had already approved it as DEQSIGA. The company also benefited from market trends.
- Anavex Life Sciences Corp is exploring commercialization efforts in Europe and seeking review for blarcamesine approval from the European Medicines Agency.
- EMA granted Orphan Drug Designation to KRRO-110, a drug candidate from Korro Bio, Inc.
- Sanofi received orphan designation from the European Medicines Agency (EMA).
- 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.
- FDA and EMA granted Rare Pediatric Disease and Orphan Drug Designations to Quoin Pharmaceuticals Ltd.
- Certara developed and utilized the Simcyp Simulator platform, which the EMA qualified for regulatory submissions, marking a successful collaboration.
- Zevra Therapeutics submitted a Marketing Authorization Application to the European Medicines Agency for Arimoclomol, targeting Niemann-Pick Disease Type C.
- 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.