A comprehensive view of U.S. Food and Drug Administration (FDA). This page highlights a small sample of our full coverage.
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Recent Articles

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Gilead resubmits application to FDA for approval of long-acting injectable HIV drug lenacapavir after FDA refused authorization in February due to drug’s compatibility with borosilicate glass vial; Gilead now using aluminosilicate glass vial for drug

Commentary: FDA banning Juul e-cigarettes in US market creates US$1B opportunity for other brands, as vape sector generates about US$7B in annual sales; Juul estimated to have 33% market share, and Cowen notes 'there's a lot of market share for grabs'

FDA approves Cybin’s New Drug Application for clinical trial evaluating oral CYB003 deuterated psilocybin analog to treat major depressive disorder; drug is first novel psilocybin analog to start clinical development, with Phase1/2a trial starting soon

Celgene’s US$6.4B lawsuit against Bristol Myers Squibb over contingent payouts for three therapies can continue US district court rules; Celgene shareholders allege Bristol Myers did not make sufficient effort to have drugs approved by FDA

FDA clears Bristol Myers Squibb’s Breyanzi lisocabtagene maraleucel cell therapy to treat large B-cell lymphoma in patients not eligible for stem cell transplant; drug uses genetically modified immune cells that fight cancer

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