1차 출처 기록
결정급보완요구서한 (CRL)
Moderna, mRNA-1010 계절성 독감 백신에 대해 FDA로부터 Refusal-to-File 서한 수령
FDA의 CBER는 2026년 2월 3일 Moderna에 mRNA-1010의 BLA 검토를 개시하지 않을 것이라고 통지하고 Refusal-to-File 서한을 발행했습니다. 이는 계절성 인플루엔자 백신 후보물질에 대한 규제 검토 절차를 중단시킵니다.
핵심 사실
출처 발췌
mrna-20260203 0001682852 false 0001682852 2026-02-03 2026-02-03 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 3, 2026 MODERNA, INC. (Exact name of registrant as specified in its charter) Delaware 001-38753 81-3467528 (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.) 325 Binney Street Cambridge , MA 02142 (Address of principal executive offices) (Zip code) Registrant’s telephone number, including area code: ( 617 ) 714-6500 Not Applicable (Former name or former address, if changed since last report) Check the appropriate box below if the Form 8-K fi