International — European Commission & United States — Food and Drug Administration
34 shared events · Importance 7 · Last updated Jun 16, 2026
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Business
International — European Commission: The International — European Commission granted Orphan Drug Designation to alixorexton for narcolepsy, providing regulatory support and potential market exclusivity in Europe.
United States — Food and Drug Administration: The United States — Food and Drug Administration granted Orphan Drug Designation to alixorexton for idiopathic hypersomnia, facilitating its development and potential market entry in the U.S.
Jun 15, 2026 · 7 articles
Tech
International — European Commission: The International — European Commission has granted Lonvoguran ziclumeran Orphan Drug Designation (ODD), providing incentives for its development due to its rarity.
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
International — European Commission: The International — European Commission granted marketing authorization for DAYBU, a key regulatory decision enabling market access across the EU.
United States — Food and Drug Administration: The FDA previously approved trofinetide in the US, establishing its efficacy and safety.
Aug 24, 2026 · 7 articles
Tech
International — European Commission: The International — European Commission>>> previously granted marketing authorization for HYMPAVZI>>> for certain hemophilia patients, indicating broader international regulatory progress for the drug.
United States — Food and Drug Administration: The United States — Food and Drug Administration>>> granted the expanded approval for HYMPAVZI, validating its efficacy and safety for a broader patient population. This action reflects the agency's role in regulating and approving pharmaceutical products in the United States>>>.
Jun 08, 2026 · 7 articles
Business
International — European Commission: The International — European Commission has already granted conditional marketing authorization for Allogeneic umbilical cord-derived CD34- cells, non-expanded/dorocubicel in Europe, indicating its potential.
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
International — European Commission: The International — European Commission granted orphan drug designation for deucrictibant, indicating its recognition of the drug's potential for treating rare diseases.
United States — Food and Drug Administration: The United States — Food and Drug Administration accepted Pharvaris' New Drug Application for deucrictibant IR and set a PDUFA target action date of April 23, 2027. This action is a crucial step in the regulatory process for the drug's potential approval.
Jul 06, 2026 · 6 articles
Business
International — European Commission: The International — European Commission has already granted Marketing Authorization for LYTENAVA (bevacizumab gamma) in the EU for the treatment of wet AMD, indicating prior regulatory success in other regions.
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) granted MiNK Therapeutics' appeal, concluding that substantial evidence of effectiveness has been established for LYTENAVA, and will now review the resubmitted BLA with a decision expected within 60 days.
May 26, 2026 · 7 articles
Regulatory
International — European Commission: The International — European Commission granted Orphan Drug Designation for ATH434, supporting its development in Europe.
United States — Food and Drug Administration: The FDA provided regulatory guidance and agreed to a single pivotal trial design for ATH434, facilitating the drug's development for MSA.
Jul 07, 2026 · 7 articles
Tech
International — European Commission: The International — European Commission has granted Tennessee State Route 201 orphan medicinal product designation, which could facilitate its development and market access in Europe.
United States — Food and Drug Administration: The United States — Food and Drug Administration has granted Tennessee State Route 201 Fast Track, Orphan Drug, and Rare Pediatric Drug Designations, indicating regulatory recognition of the therapy's potential.
Jun 02, 2026 · 8 articles
Business
International — European Commission: The International — European Commission previously granted marketing authorization for eptinezumab for migraine prophylaxis in adults.
United States — Food and Drug Administration: The United States — Food and Drug Administration previously approved eptinezumab for preventive migraine treatment in adults.
May 26, 2026 · 7 articles
Business
International — European Commission: 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
Business
International — European Commission: The International — European Commission approved PEDMARQSI in June 2023, enabling European commercialization. No new regulatory actions are part of this event.
United States — Food and Drug Administration: The FDA approved PEDMARK in September 2022, which is a key regulatory milestone for Fennec. This event does not involve new FDA actions.
Aug 05, 2026 · 6 articles
Business
International — European Commission: Granted Orphan Drug Designation to HLX22 for gastric cancer.
United States — Food and Drug Administration: Granted Orphan Drug Designation to HLX22 for gastric cancer.
Aug 06, 2026 · 6 articles
Business
International — European Commission: The International — European Commission granted Marketing Authorization for LYTENAVA in the EU. The offering does not directly affect the International — European Commission.
United States — Food and Drug Administration: The FDA approved LYTENAVA for the treatment of wet AMD. The offering does not directly affect the FDA.
Aug 12, 2026 · 7 articles
Business
International — European Commission: The International — European Commission approved PEDMARQSI, another key product of Fennec Pharmaceuticals, which provides background on the company's operational success.
United States — Food and Drug Administration: The United States — Food and Drug Administration approved PEDMARK, a key product of Fennec Pharmaceuticals, which provides background on the company's operational success.
May 18, 2026 · 7 articles
Tech
International — European Commission: The International — European Commission is mentioned as having approved AGAMREE for Duchenne muscular dystrophy in the EU, indicating the drug's established regulatory status.
United States — Food and Drug Administration: The United States — Food and Drug Administration is mentioned as having approved AGAMREE for Duchenne muscular dystrophy in the U.S., indicating the drug's established regulatory status.
Jul 01, 2026 · 6 articles
Business
International — European Commission: The International — European Commission granted Orphan Drug Designation to deupirfenidone, recognizing its potential for treating a rare disease.
United States — Food and Drug Administration: The United States — Food and Drug Administration granted Orphan Drug Designation to deupirfenidone, acknowledging its potential for treating a rare disease.
Jul 02, 2026 · 6 articles
Regulatory
International — European Commission: Previously approved the vaccine; not directly involved in this submission.
United States — Food and Drug Administration: Previously approved the vaccine; not directly involved in this submission.
Jul 13, 2026 · 6 articles
Business
International — European Commission: The International — European Commission approved AGAMREE in the EU; not directly involved in this expansion.
United States — Food and Drug Administration: The FDA approved AGAMREE in the U.S.; not directly involved in this distribution expansion.
Jul 13, 2026 · 6 articles
Business
International — European Commission: The International — European Commission may be involved in granting marketing authorization for the medicine in the EU.
United States — Food and Drug Administration: The FDA is a regulatory body that may review future clinical trial applications and approvals for the ASO medicine.
Jul 27, 2026 · 6 articles
Tech
International — European Commission: The International — European Commission granted Etavopivat Orphan Drug designation, based on a positive opinion from the Committee for Orphan Medicinal Products of the European Union — European Medicines Agency, which will facilitate its development and potential approval in Europe.
Apr 20, 2026 · 7 articles
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