FDA decisions lack majority consensus, experts agree, possibly leading to less nuanced verdicts on new drug applications.
The FDA granted priority review to rusfertide, a potential therapy for polycythemia vera; a decision regarding approval is ...
The sNDA filing acceptance initiates substantive FDA review for Ameluz PDT in sBCC, with a target action date of Sept. 28, 2026 and no identified filing deficiencies. Approval would establish the ...
Regenerative Medicine Advanced Therapy (RMAT) designation requests update submitted to FDA with recent biomarker data ...
Agency staff "strongly recommended" a sham surgery-controlled trial be conducted before an approval filing, a stance one analyst called a "worst case scenario" for UniQure.
MIRA trial data demonstrated a 43% response with 120mg SLK, and a 29 ppt delta vs placebo (p < 0.001) at week 12. VELA-1 met all primary and key secondary endpoints with statistical significance ...
The FDA has accepted Moderna’s revised influenza vaccine filing days after controversially refusing to review the original submission, putting the biotech on track to win approval in time for the 2026 ...
HHS Spokesman Andrew Nixon told The National News Desk via email that the FDA rejected Moderna’s application for filing ...
Ocular Therapeutix reported a phase 3 win that it believes can validate its attempts to challenge Regeneron’s entrenched position in wet age-related macular degeneration (AMD) with investigational | ...
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