Record mula sa primary source
Decision-gradeComplete response letter
Nakatanggap ang Moderna ng liham ng Refusal-to-File mula sa FDA para sa bakunang mRNA-1010 laban sa seasonal flu
Noong Pebrero 3, 2026, inabisuhan ng CBER ng FDA ang Moderna na hindi nito sisimulan ang pagsusuri ng BLA para sa mRNA-1010 at naglabas ng liham ng Refusal-to-File. Ito ay nagpapahinto sa proseso ng regulatory review para sa investigational seasonal influenza vaccine.
Mahahalagang fact
- Na-file
- Peb 10, 2026, 11:02 PM
- Kaganapan
- Complete response letter
- Direksyon
- Negatibo
- Kumpanya
MRNAModerna- Asset
- mRNA-1010
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
Sipi mula sa source
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