Further Fosrenol studies
Executive Summary
EU reference member state requests additional information on Shire's Fosrenol (lanthanum carbonate), likely extending the review period into the second half of 2003. Shire expects FDA action on Fosrenol shortly...
You may also be interested in...
Shire Fosrenol “approvable”
Shire will submit additional Fosrenol (lanthanum) data and analysis prior to approval of the non-calcium binder to address issues outlined in FDA "approvable" letter, company says March 3. "Shire is initiating a dialogue with the FDA to agree [to] the balance between pre and post approval commitments which will resolve the questions" The European Union also requested additional data (1"The Pink Sheet" March 3, In Brief)...
US FDA Urges COVID-19 Transmission Risk Mitigation In Cell And Gene Therapy Manufacturing
The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.
COVID-19: US Acted To Beat Other Countries To Next 1.25M Doses Of Regeneron Cocktail
Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: