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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AGC Biologics to Manufacture First-ever FDA Approved Gene Therapy for Early-onset Metachromatic Leukodystrophy, Orchard Therapeutics’ Lenmeldy™ (atidarsagene autotemcel)
Published:
March 19, 2024
by News Direct
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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
Published:
March 18, 2024
by CE NAFTA 2.0 Newswire (Mexico)
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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
Published:
March 15, 2024
by Bristol-Myers Squibb Co.
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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
Published:
March 15, 2024
by Janssen Pharmaceutical Companies
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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
Published:
March 15, 2024
by Johnson & Johnson Services Inc.
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