US FDA
Samsung BioLogics faces FDA scrutiny over data integrity and quality issues at Korean plant
The FDA recently issued manufacturing alerts, targeting high-flying companies Samsung Biologics and Nectar Lifesciences. For Samsung Biologics, a notable player ...
Alnylam gives up on Onpattroās US expansion after FDA rejects its rare heart disease indication
Despite receiving an endorsement from an advisory committee, the FDA has reached a different conclusion regarding the benefit-risk profile of ...
Amgenās Lumakras flunks FDA expert meeting, but market withdrawal looks unlikely for now
Amgen’s groundbreaking KRAS inhibitor, Lumakras, faced a pivotal moment as the FDA’s Oncologic Drugs Advisory Committee (ODAC) convened to evaluate ...
Eli Lilly Faces Third FDA Rejection in 2023, Eczema Drug Lebrikizumab Denied Approval
Eli Lilly, which had set ambitious plans to introduce four new drugs in 2023, has faced another setback on the ...
FDA denies approval for Neffy, ARS Pharmaceuticalsā needle-free EpiPen alternative, citing safety concerns
While positive votes from FDA advisory committees often bode well for drug approvals, ARS Pharmaceuticals experienced an unexpected setback when ...
White House reports progress on easing cancer drug shortages with FDA, manufacturers
The US FDA and pharmaceutical manufacturers are making significant strides in addressing the nationwide shortage of popular cancer drugs, as ...
FDA doubts Onpattroās benefit in heart disease, Alnylam faces Pfizer hurdle
The FDA has raised significant concerns about Alnylam’s attempt to expand the use of Onpattro for the treatment of transthyretin ...
