Regenerative Medicine Advanced Therapy (RMAT) designation requests update submitted to FDA with recent biomarker data ...
After the FDA's surprise refusal to take up a review of Moderna's next-gen flu vaccine, the public disagreement between U.S.
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 ...
Ocular Therapeutix reported a phase 3 win that it believes can validate its attempts to challenge Regeneron’s entrenched ...
The news is the latest sign of the FDA’s heightened scrutiny of vaccines under Health Secretary Robert F. Kennedy Jr.
PLAINSBORO, N.J., May 2, 2025 /PRNewswire/ -- Today, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) submission for an investigational ...
Stéphane Bancel, Moderna’s chief executive officer, said that “we appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application ...
The FDA has accepted a sNDA for Ameluz topical gel, used in combination with the RhodoLED red-light lamp series, for superficial basal cell carcinoma treatment.
Sanofi SNY announced that the FDA has accepted a regulatory filing seeking to expand the use of its type 1 diabetes (T1D) drug, Tzield (teplizumab), in individuals aged one year and older. The agency ...
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 ...
HHS Spokesman Andrew Nixon told The National News Desk via email that the FDA rejected Moderna’s application for filing ...
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