FDA lifts partial clinical hold on Gilead’s blood cancer drug trials
The health regulator had placed the hold on five cancer trials in January due to an imbalance in suspected and unexpected serious…
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Browsing Tag
US FDA
Lupin receives US FDA approval for Sildenafil for oral suspension
The product will be manufactured at Lupin’s facility in Goa
US FDA declines to approve AstraZeneca treatment for chronic nasal condition
The drugmaker said the US Food and Drug Administration (FDA) had issued a complete response letter following AstraZeneca's…
Lupin gets US FDA nod to market generic product
The company has received approval from the United States Food and Drug Administration (FDA) to market the generic version of…
US FDA extends review period for expanded use of Abbvie’s psoriasis drug
The US Food and Drug Administration (FDA) was reviewing the application for the use of Skyrizi in patients aged 16 years or older…
US FDA declines to approve Amryt’s topical gel for rare skin diseases
The agency has asked Amryt to submit additional data confirming the effectiveness of the drug
Aurobindo and Sun Pharma recall products from US
While Aurobindo Pharma is recalling 1,15,776 bottles of Moxifloxacin Ophthalmic Solution, Sun Pharma is recalling 59,232 bottles…
US FDA expands deployment of Waters Corporation Software to support its medical products testing…
Transition to electronic records management system will speed data retrieval, automate essential audit and archival functions, and…
US limits use of Regeneron and Eli Lilly COVID-19 antibody treatments amid Omicron spread
The Food and Drug Administration (FDA) said the treatments are currently not cleared for use in any US states or territories, but…