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September 20, 2022
Otsuka announced that the EC has approved Lupkynis as the first oral treatment for active lupus nephritis.
September 16, 2022
EMA has recommended approval of Enjaymo for the treatment of hemolytic anemia in adult patients with cold agglutinin disease.
The White House hopes to expand US modern biotech manufacturing and reduce reliance on foreign sources of bioindustrial materials.
September 14, 2022
WHO has awarded prequalification to GSK’s Mosquirix, an approved malaria vaccine.
September 09, 2022
FDA is in jeopardy of losing its fees for assessing and approving new drugs and medical products.
September 07, 2022
Lynparza has been approved in Great Britain as an adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.
Sanofi’s Xenpozyme (olipudase alfa-rpcp) is now the only approved treatment for acid sphingomyelinase deficiency.
A new survey has demonstrated that remote audits, brought to the fore thanks to COVID-19, are not necessarily a preferred option for clients.
September 02, 2022
FDA has issued an emergency use authorization for both the Pfizer-BioNTech and Moderna bivalent COVID-19 boosters.
EMA has announced a change of plan for the IDMP.