Catatan sumber primer
PenentuSurat tanggapan lengkap
Moderna menerima surat Refusal-to-File FDA untuk vaksin flu musiman mRNA-1010
CBER FDA memberitahu Moderna pada 3 Februari 2026 bahwa mereka tidak akan memulai peninjauan BLA untuk mRNA-1010 dan menerbitkan surat Refusal-to-File. Hal ini menghentikan proses peninjauan regulasi untuk vaksin influenza musiman investigasional tersebut.
Fakta utama
- Diajukan
- 10 Feb 2026, 23.02
- Peristiwa
- Surat tanggapan lengkap
- Arah
- Negatif
- Perusahaan
MRNAModerna- Aset
- mRNA-1010
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
Kutipan sumber
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