Biologics are complex medications produced through biological processes or from living organisms such as proteins and genes. Biosimilars are what they sound like — similar to, but not the same as, an ...
The FDA approved depemokimab as an add-on maintenance treatment in patients aged at least 12 years with severe asthma and an eosinophilic phenotype, according to a press release from GSK.Depemokimab ...
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FDA to streamline approvals for generic biological drugs in latest move targeting health costs
The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...
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FDA to speed up approvals of generic biologic medicines as Trump targets high drug costs
The Food and Drug Administration said it will take steps to speed up the process of developing generic versions of complex biological drugs, in a bid to increase cheaper competition for expensive ...
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First Twice-Yearly Biologic Approved for Severe Eosinophilic Asthma
The FDA approved depemokimab (Exdensur) as the first ultra-long-acting biologic with twice-yearly dosing approved for patients with severe asthma with an eosinophilic phenotype, GSK announced.
The FDA has accepted a biologics license application from Inovio for a potential treatment for adults with recurrent respiratory papillomatosis. Although the application was filed under the ...
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