The FDA has updated guidance outlining how it applies regulatory flexibility to chemistry, manufacturing and control requirements for cell and gene therapies. The agency said the approach is meant to ...
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 ...
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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 ...
Health system pharmacists and clinicians are monitoring a wave of drug approvals expected throughout 2026, including first-in-class therapies and expanded uses of existing drugs with implications for ...
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MLTX stock extends rally as FDA feedback spurs bullish brokerage action – retail speculates on potential M&A conversations
H.C. Wainwright raised MoonLake’s price target to $32 from $26 and maintained a ‘Buy’ rating. ・BTIG said the FDA approval ...
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