一次情報の記録
FDAは、CannEpilがMUMSプログラムの下でマイナー用途に該当すると判断し、犬の骨がん関連疼痛に対する条件付き承認経路の適格性を確立しました。マイナー用途の地位はNADA承認まで維持されます。企業は2026年11月19日にFDA CVMとの事前提出会議を開催します。
EX-99.1 2 e7991_ex99-1.htm EXHIBIT 99.1 EXHIBIT 99.1 Endovia and Lupvindol BioSciences Announce FDA Determination that CannEpil® for Canine Bone Cancer Pain Qualifies as a Minor Use, Establishing Eligibility for Conditional Approval Pathway Companies to Meet Formally with FDA’s Center for Veterinary Medicine on November 19th for Pre-Submission Conference; U.S. Manufacturing Strategy Underway to Support Potential 2027 Veterinary Product Launch FORT LAUDERDALE, Fla. — October 5, 2026 — Endovia Health Sciences, Inc. (“Endovia” or the “Company”) (NYSE American: EDVA), in association with Lupvindol BioSciences (“Lupvindol”), today announced that the U.S. Food and Drug Administration’s (“FDA”) Center for Veterinary Medicine has determined that the proposed use of CannEpil®, an investigationa