International — European Commission & United States — Food and Drug Administration
18 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 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 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
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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