The FDA has approved Hyrnuo for some with locally advanced or metastatic non-squamous non–small cell lung cancer with ...
The U.S. Food and Drug Administration (FDA) approved Poherdy (pertuzumab-dpzb) as the first interchangeable biosimilar to ...
Onasemnogene abeparvovec-brve is the first gene replacement therapy approved for SMA patients aged 2 years and older, expanding access beyond infants. Phase 3 trials demonstrated significant motor ...
The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies ...
The FDA approved Novartis’ Itvisma (onasemnogene abeparvovec-brve), the company’s first and only gene replacement therapy for spinal muscular atrophy in children 2 and older, as well as for teens and ...
Zantac and other ranitidine products were withdrawn nationwide in April 2020 over concerns an impurity could cause cancer.
The FDA approved the first drug from an emerging class of medicines for patients with a chronic, autoimmune kidney disease.
The lab, led by Carleara Weiss, explores the relationship between Alzheimer’s disease and biomarkers of neurodegeneration, ...
In 2024, the FDA granted a record 63 designations to antibody drug conjugates (ADCs), nearly double the previous high of 35 ...
The clinical trials new drugs and devices must undergo for approval by the U.S. Food and Drug Administration hold the drugs to varying degrees of approval, according to a study published in the ...
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