Healthcare, Pharmaceuticals, FDA, rare disease drug, approval, Disc Medicine
February 13, 2026
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US FDA declines to approve Disc Medicine’s rare disease drug

On February 13, 2026, the U.S. Food and Drug Administration turned down the approval of Disc Medicine’s experimental treatment, sending the company’s stock tumbling 31.6% to $48.90. The drug, bitopertin, was being developed to help patients suffering from erythropoietic protoporphyria, a rare genetic metabolic disorder. Erythropoietic protoporphyria arises from a deficiency in the ferrochelatase enzyme, […]

FDA, Moderna, influenza vaccine, regulatory review, vaccine approval
February 11, 2026
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FDA refuses to review Moderna’s influenza vaccine application

The U.S. Food and Drug Administration declined to review Moderna’s application for its mRNA‑1010 influenza vaccine, a decision that sent the company’s shares down 8% in extended trading. In its refusal‑to‑file letter, the FDA said Moderna’s choice to compare the new vaccine to an already licensed standard‑dose seasonal flu shot was the sole reason for […]