European Union — European Medicines Agency
Tracked across 65 events · 964 articles · First seen Feb 10, 2025 · Last active Aug 19, 2026
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Regulatory
Impact: The European Union — European Medicines Agency's CHMP recommended the revocation of the marketing authorization for TAVNEOS, impacting its availability in the EU.
Jun 26, 2026 · 9 articles
Tech
Impact: The European Union — European Medicines Agency identified favipiravir as the most plausible candidate for hantavirus treatment under clinical trial or compassionate use protocols.
May 28, 2026 · 6 articles
Business
Impact: The European Union — European Medicines Agency conditionally approved Imlifidase and requested the PAES study, which has now been successfully completed, paving the way for a full marketing authorization application.
May 27, 2026 · 6 articles
Regulatory
On July 24, 2026, the European Union — European Medicines Agency's European Union — Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion on the Marketing Authorization Application for arimoclomol, branded Meplyffa,…
Impact: The European Union — European Medicines Agency, through its CHMP committee, issued the negative opinion that triggered the stock decline. Its decision is pivotal to Zevra's European market access for arimoclomol.
Jul 24, 2026 · 29 articles
Regulatory
The European Union — European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for PF-07307405, a 6-valent OspA-based Lyme disease vaccine candidate co-developed by Pfizer and Valneva SE. The validation allows the EMA…
Impact: The EMA is the regulatory body validating and assessing the application. Its decision will determine market access in Europe.
Aug 14, 2026 · 12 articles
Regulatory
Impact: The European Union — European Medicines Agency (EMA) is the overarching regulatory body whose CHMP adopted the positive opinion for DAYBU, facilitating its potential market entry in the EU.
Jun 26, 2026 · 6 articles
Tech
Impact: The European Union — European Medicines Agency granted PRIME designation for Privosegtor, another significant regulatory milestone that supports its development in Europe.
Jun 11, 2026 · 7 articles
Regulatory
Impact: The EMA initiated a phased review of daraxonrasib, accelerating the assessment process for a potential new pancreatic cancer therapy.
Jul 07, 2026 · 7 articles
Business
Impact: The European Union — European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Dupixent for chronic spontaneous urticaria (CSU) in the European Union.
Feb 24, 2026 · 8 articles
Tech
Impact: The European Union — European Medicines Agency has released detailed guidance on computerized systems and data management, stressing the importance of secure, attributable and contemporaneous records, which accelerates the move toward automation.
Apr 07, 2026 · 8 articles
Regulatory
Impact: The European Union — European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on Omeros Corporation's drug narsoplimab, directly causing the company's stock price drop and triggering the subsequent investigation.
Jul 01, 2026 · 12 articles
Business
Impact: The European Union — European Medicines Agency>>> is involved in the approval process for Imlifidase>>>, with a payment contingent on its filing acceptance.
May 19, 2026 · 7 articles
Tech
Impact: The European Union — European Medicines Agency has granted Lonvoguran ziclumeran Priority Medicines (PRIME) Designation, which supports the development of medicines that address unmet medical needs.
Jun 01, 2026 · 6 articles
Domestic
Impact: The European Union — European Medicines Agency recently recommended approval of Novo Nordisk's Semaglutide pill, which could pave the way for the first oral weight-loss drug in Europe, complementing France's reimbursement initiative.
May 28, 2026 · 6 articles
Regulatory
Impact: Immunome plans to submit a Marketing Authorization Application to the EMA by end of 2026, making the EMA a future regulatory body for varegacestat in Europe.
Jul 08, 2026 · 6 articles
Business
Impact: The EMA recommended expanding mRESVIA's license to all adults 18+, which may increase vaccine uptake.
Jul 09, 2026 · 6 articles
Regulatory
Impact: The EMA is also reviewing the combination for the same indication.
Jul 22, 2026 · 6 articles
Business
Impact: The EMA granted PRIME status to PentixaFor, providing enhanced support for its development and approval in European Union — Europe.
Jul 15, 2026 · 10 articles
Business
Impact: The EMA accepted the Marketing Authorisation Application for senaparib, a regulatory step that is critical for European Union — European market entry. Approval is expected in H2 2026.
Jul 31, 2026 · 8 articles
Tech
Impact: The European Union — European Medicines Agency provides statistics on the prevalence of Dementia UK in Europe, underscoring the regional impact of the condition.
Jan 02, 2026 · 7 articles
Tech
Impact: The European Union — European Medicines Agency granted IBM System/4 Pi Orphan Drug designation, which can expedite its development and review process in Europe.
Jun 24, 2026 · 6 articles
Regulatory
Impact: The European Union — European Medicines Agency (EMA) is mentioned as a target for a Marketing Authorization Application (MAA) in 2026 for INmune Bio Inc.'s CORDStrom platform, indicating future regulatory efforts in the European Union.
Jun 25, 2026 · 6 articles
Business
Impact: The European Union — European Medicines Agency has granted orphan medicinal product designation, advanced therapy medicinal product (ATMP) classification, and priority medicines (PRIME) designation to Allogeneic umbilical cord-derived CD34- cells, non-expanded/dorocubicel.
Jun 10, 2026 · 6 articles
Business
Impact: The European Union — European Medicines Agency has granted Orphan Drug Designation to G2B-002 for DIPG and pGBM, providing a positive regulatory status for the drug's development in Europe.
Jun 08, 2026 · 7 articles
Business
Impact: The European Union — European Medicines Agency granted Priority Medicines (PRIME) designation to Oculis's Privosegtor, indicating its importance.
Jun 08, 2026 · 6 articles
Business
Impact: The European Union — European Medicines Agency (EMA) has granted Orphan Drug designation to zeleciment basivarsen, indicating Dyne Therapeutics' pursuit of approval pathways outside of the U.S.
Jun 03, 2026 · 6 articles
Business
Swedish Orphan Biovitrum (Sobi) and Innate Pharma announced a strategic partnership to develop and commercialize lacutamab, a first-in-class anti-KIR3DL2 antibody for cutaneous T-cell lymphoma (CTCL). Under the agreement, Innate will conduct the TELLOMAK-3 Phase 3…
Impact: Granted PRIME designation for lacutamab in Sézary syndrome, supporting accelerated assessment.
Aug 10, 2026 · 10 articles
Business
Cellectar Biosciences, a late-stage clinical biopharmaceutical company, announced its second quarter 2026 financial results and provided a corporate update on August 13, 2026. The company reported cash and cash equivalents of $34.0 million as of…
Impact: The EMA has granted PRIME designation to iopofosine I 131, which may facilitate regulatory review in Europe, though no immediate actions were reported.
Jul 30, 2026 · 6 articles
Tech
Impact: The European Union — European Medicines Agency's Committee for Orphan Medicinal Products provided a positive opinion for Etavopivat, leading to its Orphan Drug designation by the International — European Commission.
Apr 20, 2026 · 7 articles
Tech
Impact: The European Union — European Medicines Agency is mentioned as the regulatory body that currently has no approved Andes hantavirus vaccines, indicating the market opportunity for the new vaccine.
Jun 12, 2026 · 6 articles
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European Union — European Medicines Agency adopted negative opinion Zevra TherapeuticsZevra CHMP Negative...
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European Union — European Medicines Agency accepted application PfizerEMA validates...
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European Union — European Medicines Agency accepted application Valneva SEEMA validates...
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Zevra Therapeutics requested re-examination European Union — European Medicines AgencyZevra CHMP Negative...
United Kingdom — Medicines and Healthcare products Regulatory Agency
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European Union — European Medicines Agency
United Kingdom — Medicines and Healthcare products Regulatory Agency
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European Union — European Medicines Agency
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