European Union — European Medicines Agency & United States — Food and Drug Administration
51 shared events · Importance 5 · Last updated Aug 13, 2026
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European Union — European Medicines Agency: The European Union — European Medicines Agency granted PRIME designation for Privosegtor, another significant regulatory milestone that supports its development in Europe.
United States — Food and Drug Administration: The United States — Food and Drug Administration granted Breakthrough Therapy designation for Privosegtor, a key regulatory milestone that accelerates its development and potential approval.
Jun 11, 2026 · 7 articles
Regulatory
European Union — European Medicines Agency: The EMA initiated a phased review of daraxonrasib, accelerating the assessment process for a potential new pancreatic cancer therapy.
United States — Food and Drug Administration: The FDA is reviewing a rolling NDA for daraxonrasib under a priority voucher program, which could expedite U.S. approval.
Jul 07, 2026 · 7 articles
Tech
European Union — European Medicines Agency: 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.
United States — Food and Drug Administration: The United States — Food and Drug Administration encourages the adoption of advanced manufacturing technologies and continuous production models, reinforcing the shift from reactive to proactive compliance strategies in the pharmaceutical industry.
Apr 07, 2026 · 8 articles
Business
European Union — European Medicines Agency: 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.
United States — Food and Drug Administration: The United States — Food and Drug Administration accepted the Biologics License Application for imlifidase in February 2026, indicating potential future market expansion for the drug in the US.
May 27, 2026 · 6 articles
Regulatory
European Union — European Medicines Agency: 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.
United States — Food and Drug Administration: The FDA accepted the NDA for review and will decide on approval by April 28, 2027, playing a critical regulatory role in the event.
Jul 08, 2026 · 6 articles
Regulatory
European Union — European Medicines Agency: The EMA is also reviewing the combination for the same indication.
United States — Food and Drug Administration: The FDA accepted the application for Priority Review and will decide by Q4 2026.
Jul 22, 2026 · 6 articles
Business
European Union — European Medicines Agency: 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.
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) is the regulatory body responsible for granting Accelerated Approval and Priority Review for zeleciment basivarsen, which is crucial for its potential U.S. launch. The FDA has already granted Breakthrough Therapy, Orphan Drug, and Fast Track designations to zeleciment basivarsen.
Jun 03, 2026 · 6 articles
Business
European Union — European Medicines Agency: The EMA has granted PRIME designation to iopofosine I 131, which may facilitate regulatory review in Europe, though no immediate actions were reported.
United States — Food and Drug Administration: The FDA is the regulatory body for the planned NDA submission of iopofosine I 131 under the Accelerated Approval Program, a critical milestone for Cellectar.
Jul 30, 2026 · 6 articles
Tech
European Union — European Medicines Agency: 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.
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) has granted Lonvoguran ziclumeran Orphan Drug and RMAT Designation, indicating its potential importance and expediting its review process.
Jun 01, 2026 · 6 articles
Regulatory
European Union — European Medicines Agency: The European Union — European Medicines Agency has granted Orphan Drug Designation and Advanced Therapy Medicinal Product designation to Deramiocel, indicating its potential importance in Europe, though the current event focuses on U.S. regulatory review.
United States — Food and Drug Administration: The United States — Food and Drug Administration's Cellular, Tissue, and Gene Therapies Advisory Committee is convening a meeting to review Paragon Therapeutics' Biologics License Application for Deramiocel, which is a critical step in the regulatory approval process for the drug.
Jun 26, 2026 · 6 articles
Regulatory
European Union — European Medicines Agency: The European Union — European Medicines Agency>>> has validated a Marketing Authorization Application for AVT16 and AVT80, indicating progress in European markets.
United States — Food and Drug Administration: The United States — Food and Drug Administration>>> accepted the Biologics License Application for AVT16, initiating the review process for this proposed interchangeable biosimilar.
Jun 08, 2026 · 11 articles
Regulatory
European Union — European Medicines Agency: Granted orphan drug designation; not directly involved in the FDA setback.
United States — Food and Drug Administration: Regulator whose briefing documents and advisory committee vote triggered the stock collapse and legal actions.
Jul 27, 2026 · 293 articles
Business
European Union — European Medicines Agency: The EMA granted PRIME status to PentixaFor, providing enhanced support for its development and approval in European Union — Europe.
United States — Food and Drug Administration: The FDA granted Fast Track designation to PentixaFor, facilitating its development and regulatory review.
Jul 15, 2026 · 10 articles
Business
European Union — European Medicines Agency: The European Union — European Medicines Agency>>> is involved in the approval process for Imlifidase>>>, with a payment contingent on its filing acceptance.
United States — Food and Drug Administration: The United States — Food and Drug Administration>>> accepted the Biologics License Application for imlifidase in the US, indicating future market potential outside the current deal.
May 19, 2026 · 7 articles
Tech
European Union — European Medicines Agency: The European Union — European Medicines Agency granted IBM System/4 Pi Orphan Drug designation, which can expedite its development and review process in Europe.
United States — Food and Drug Administration: The United States — Food and Drug Administration granted IBM System/4 Pi Orphan Drug designation, which can expedite its development and review process.
Jun 24, 2026 · 6 articles
Regulatory
European Union — European Medicines Agency: 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.
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) is a target for a Biologics License Application (BLA) submission in early 2027 for INmune Bio Inc.'s CORDStrom platform, indicating future regulatory efforts in the United States. The FDA also granted Fast Track designation for XPro1595.
Jun 25, 2026 · 6 articles
Business
European Union — European Medicines Agency: 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.
United States — Food and Drug Administration: The United States — Food and Drug Administration has granted orphan drug designation and regenerative medicine advanced therapy (RMAT) designations to Allogeneic umbilical cord-derived CD34- cells, non-expanded/dorocubicel.
Jun 10, 2026 · 6 articles
Business
European Union — European Medicines Agency: 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.
United States — Food and Drug Administration: The United States — Food and Drug Administration has granted Orphan Drug Designation to G2B-002 for DIPG and pGBM, which is a positive regulatory status for the drug's development.
Jun 08, 2026 · 7 articles
Business
European Union — European Medicines Agency: The European Union — European Medicines Agency granted Priority Medicines (PRIME) designation to Oculis's Privosegtor, indicating its importance.
United States — Food and Drug Administration: The United States — Food and Drug Administration granted Breakthrough Therapy designation to Oculis's Privosegtor, highlighting its potential.
Jun 08, 2026 · 6 articles
Business
European Union — European Medicines Agency: Granted PRIME designation for lacutamab in Sézary syndrome, supporting accelerated assessment.
United States — Food and Drug Administration: Granted Fast Track and Breakthrough Therapy designations to lacutamab, facilitating its development and review.
Aug 10, 2026 · 10 articles
Regulatory
European Union — European Medicines Agency: The EMA is the regulatory body validating and assessing the application. Its decision will determine market access in Europe.
United States — Food and Drug Administration: The FDA is mentioned in the context of a separate approval for Pfizer's Hympavzi, not directly related to this event.
Aug 14, 2026 · 12 articles
Regulatory
European Union — European Medicines Agency: The EMA's advisory committee recommended approval, which preceded the International — European Commission's decision.
United States — Food and Drug Administration: The FDA previously approved trofinetide in the US, establishing its efficacy and safety.
Aug 24, 2026 · 7 articles
Business
European Union — European Medicines Agency: The European Union — European Medicines Agency has granted zilganersen Orphan Drug designation for Alexander disease.
United States — Food and Drug Administration: The United States — Food and Drug Administration is currently reviewing zilganersen with a PDUFA action date of September 22, 2026, and has granted it Breakthrough Therapy, Fast Track, Rare Pediatric Disease, and Orphan Drug designations.
Jun 25, 2026 · 6 articles
Business
European Union — European Medicines Agency: The EMA's prior conditional approval and PRIME designation support Idefirix's regulatory standing in Europe, though not directly impacted by this event.
United States — Food and Drug Administration: The FDA's acceptance of the BLA and PDUFA date of December 19, 2026, are key upcoming regulatory milestones for GT Biopharma in the US market.
Aug 18, 2026 · 6 articles
Regulatory
European Union — European Medicines Agency: Roche>>> is pursuing further regulatory filings for Atezolizumab>>> with the European Union — European Medicines Agency>>>.
United States — Food and Drug Administration: The United States — Food and Drug Administration>>> granted Priority Review for Roche>>>'s Atezolizumab, indicating a potential new treatment option for colon cancer patients.
Jun 11, 2026 · 6 articles
Tech
European Union — European Medicines Agency: The European Union — European Medicines Agency reviewed IDEFIRIX as part of its PRIority Medicines program, supporting its conditional marketing approval in Europe.
United States — Food and Drug Administration: The United States — Food and Drug Administration accepted the Biologics License Application for imlifidase, setting a PDUFA action date for December 19, 2026.
May 25, 2026 · 6 articles
Regulatory
European Union — European Medicines Agency: The European Union — European Medicines Agency (EMA) is currently reviewing Lerociclib for regulatory approval, which could expand its market reach beyond the United States and China.
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) has already approved Lerociclib, indicating its efficacy and safety profile, which supports its regulatory review in other regions.
Jun 26, 2026 · 8 articles
Business
European Union — European Medicines Agency: The European Union — European Medicines Agency is mentioned as a regulatory agency whose harmonized frameworks are streamlining biosimilar approval pathways, benefiting companies like EirGenix.
United States — Food and Drug Administration: The United States — Food and Drug Administration is mentioned as a regulatory agency whose harmonized frameworks are streamlining biosimilar approval pathways, benefiting companies like EirGenix.
Jun 30, 2026 · 6 articles
Business
European Union — European Medicines Agency: Approved Palsonify for acromegaly in the EU.
United States — Food and Drug Administration: The FDA approved Palsonify in 2025, enabling its commercial availability. The agency's regulatory decisions are relevant to the value of the acquired assets.
Jul 06, 2026 · 34 articles
Tech
European Union — European Medicines Agency: The European Union — European Medicines Agency's CHMP adopted a positive opinion recommending the European Marketing Authorization of REDEMPLO (plozasiran), which is a significant step towards its approval in Europe.
United States — Food and Drug Administration: The United States — Food and Drug Administration previously approved REDEMPLO (plozasiran) and granted it Breakthrough Therapy designation for severe hypertriglyceridemia, indicating its regulatory significance.
May 26, 2026 · 6 articles
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