neffy (epinephrine nasal spray) is the first alternative to epinephrine administered by autoinjector or syringe and is comparable in efficacy to the gold standard.
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The Shield blood test is approved for primary CRC screening in adults 45 years and older at average risk for the disease.
The submission is based on data from OASIS trials that showed elinzanetant significantly reduced the frequency and severity of moderate-to-severe VMS associated with menopause.
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Lack of dosing experience and errors with converting measurement units may lead to overdosing, the agency reported.
The FDA requested an additional human factors study and more technical data on the final commercial product.
ICYMI: A quick look at 7 key drugs FDA-approved in the second quarter for conditions commonly seen in primary care.
Your daily dose of the clinical news you may have missed.
Your daily dose of the clinical news you may have missed.