FDA: Safety Label Changes Required for BCMA-, CD19-Directed CAR T-Cell Therapies
The FDA is requiring new safety information be included in the labeling for all BCMA- or CD19-directed autologous CAR T-cell immunotherapies.
Source: empr.com
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FDA Roundup: January 23, 2024
/PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced the...
Source: prnewswire.com
IMFINZI® (durvalumab) plus transarterial chemoembolization (TACE) and bevacizumab reduced the risk of disease progression or death by 23% vs. TACE in liver cancer eligible for embolization
EMERALD-1 is first global Phase III trial to show improved clinical outcome for systemic therapy in combination with TACE in this setting ...
Source: marketscreener.com
FDA Adds Warning to Prolia Label Regarding Hypocalcemia Risk in CKD
In patients with advanced chronic kidney disease, treatment with Prolia (denosumab) increases the risk of severe hypocalcemia, according to an updated FDA safety alert.
Source: empr.com
Acorda Therapeutics to Regain Global Commercialization Rights to FAMPYRA® by January 2025
Acorda Therapeutics, Inc. today announced it will regain global commercialization rights to FAMPYRA® following a decision by Biogen to terminate the license and collaboration agreement between the...
Source: marketscreener.com