FDA's advisory committee voted 9-0 that Moderna's mRNA flu vaccine mFlusiva benefits outweigh risks for adults 50-64 and 65+, clearing a key hurdle before an Aug. 5, 2026 decision. The FDA initially declined to review the BLA before reversing course.
The FDA has agreed to review Moderna's mRNA flu vaccine after initially rejecting it, with a decision expected by August 2026. The reversal occurs amid a contraction in the vaccine sector, with funding drops and layoffs under the Trump administration.
Crispr Therapeutics AG trades at $47.78 with a $4.78B market cap, while Moderna trades at $61.82 with a $25.06B market cap, about 5.2 times larger. Both face losses, but CRISPR's Casgevy approval and Moderna's pipeline advances shape divergent analyst outlooks.
The FDA reversed its initial rejection of Moderna's mRNA flu vaccine, agreeing to a normal review after public backlash, while a federal judge invalidated the ACIP advisory committee, leaving the US without functioning vaccine oversight. Moderna's vaccine showed 26.6% greater efficacy than standard flu shots in clinical trials.
FDA's vaccine advisory committee unanimously recommended Moderna's mRNA flu vaccine mFlusiva for adults 50 and over, the committee's first new vaccine review since 2023. The FDA expects an approval decision by Aug 5, 2026.
An FDA advisory panel unanimously recommended approval of Moderna's mRNA flu vaccine mFlusiva for adults 50 and older. The vaccine showed a 27% reduction in flu cases versus a standard shot. A final FDA decision is expected by early August.
Kenya is building local vaccine manufacturing capacity through a WHO-supported mRNA technology transfer project and a three-phase strategy focused on childhood vaccines. The country aims to reduce reliance on imports, with a fill-and-finish facility in Embakasi expected by 2027 and first locally produced vaccines by 2028.
The UK has begun a 4,000-volunteer H5N1 bird flu vaccine trial using mRNA technology. The study will assess safety and immune response, with CEPI providing £40m in funding.
Rznomics said it will present interim AACR results for liver cancer candidate RZ-001 from a U.S. trial in patients with hepatocellular carcinoma. Tumor-shrinking responses were observed, and about 23% experienced complete disappearance of cancer cells.
CAMP4 Therapeutics announced Nasdaq inducement stock option grants for newly hired employees in February and April 2026. The awards covered 51,000 shares in total and vest over four years.
