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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AGC Biologics to Manufacture First-ever FDA Approved Gene Therapy for Early-onset Metachromatic Leukodystrophy, Orchard Therapeutics’ Lenmeldy™ (atidarsagene autotemcel)

Mexico's Ministry of Economy rejects USDA's new 'Product of USA ' labeling rule, considering it discriminatory to Mexican producers and potentially harmful to binational production chains

FDA Advisory Committee votes in favor of Bristol Myers Squibb’s and 2seventy bio’s Abecma for triple-class exposed multiple myeloma in earlier lines of therapy

FDA Oncologic Drugs Advisory Committee recommends J&J's CARVYKTI ciltacabtagene autoleucel for the earlier treatment of relapsed or refractory multiple myeloma; an estimated 35,000 people are diagnosed with multiple myeloma in the US annually

FDA advisory committee recommends J&J's drug CARVYKTI for the treatment of multiple myeloma in adult patients who've received at least one prior line of therapy; a decision from FDA expected by April 5, 2024

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