By: Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research Protecting patients is at the core of what we do at the U.S. Food and Drug Administration. Now the FDA is providing additional resources to help consumers understand the risks associated with unapproved stem cell, exosome, and other products marketed as regenerative medicine products
Some of the most promising advances in cancer treatment have centered on immunotherapies that rev up a patients immune system to attack cancer.
This article examines US regulations and guidance documents for regenerative medicine advanced therapies (RMATs). The author describes the field of regenerative medicine, noting that it is expanding at an accelerated pace, and outlines some of the common terms associated with it. He also addresses the application process for these therapies, accelerated regulatory pathways, market access, and the outlook for RMATs
Visit the News Hub Mouse study suggests strategy may work against variety of cancers Researchers at Washington University School of Medicine in St. Louis have combined two types of immunotherapy into a single treatment that may be more effective and possibly safer than current immunotherapies for blood cancers.
Trusted Business Insights answers what are the scenarios for growth and recovery and whether there will be any lasting structural impact from the unfolding crisis for the Cell Therapy market. Trusted Business Insights presents an updated and Latest Study on Cell Therapy Market 2019-2026. The report contains market predictions related to market size, revenue, production, CAGR, Consumption, gross margin, price, and other substantial factors.
LEXINGTON,Mass., July 21, 2020 /PRNewswire/ --Agenus Inc.(NASDAQ: AGEN), an immuno-oncology(I-O) companywith apipelineofimmunecheckpointantibodies, adoptive cell therapies and cancer vaccines,announcedtoday that Dr.
CRANFORD, N.J., July 22, 2020 /PRNewswire/ --Citius Pharmaceuticals, Inc.
The Inventia Skin team leading the skin regeneration revolution.
HOUSTON, July 21, 2020 /PRNewswire/ --FibroGenesis announced today new data supporting use of its PneumoBlast product in the battle against COVID-19.Using the widely accepted bleomycin model of lung scarring (fibrosis), Company scientists have demonstrated the administration and use of PneumoBlast induced a 51% reduction of lung fibrosis,which was statistically significant (p < .005).
DetailsCategory: AntibodiesPublished on Friday, 24 July 2020 14:39Hits: 200 STOCKHOLM, Sweden I July 24, 2020 I Swedish Orphan Biovitrum AB (publ) (Sobi) (STO:SOBI) today announced that the Committee for Medicinal Products for Human use (CHMP) has adopted a negative opinion recommending a refusal of the marketing authorisation for emapalumab for the treatment of primary haemophagocytic lymphohistiocytosis (HLH) in children under 18 years of age in Europe.
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