Summary : Qelbree (i.e. SPN-812) is a nonstimulant ADHD medication containing a serotonin norepinephrine modulating agent approved by the FDA to treat attention deficit…
U.S FDA
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Bristol Myers SquibbRegulatoryU.S FDA
BMS Scores FDA Approval for Novel HCM Treatment Camzyos (Mavacamten)
by adminby adminSummary : Camzyos (mavacamten), the first FDA-approved cardiac myosin inhibitor that directly addresses the root of obstructive hypertrophic cardiomyopathy, has been authorised…
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Summary : HYFTOR™ is the first topical treatment approved by the FDA for facial angiofibroma in individuals with tuberous sclerosis complex (TSC) 6…
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Summary : The Venus VivaTM will now make its American premiere, having already established itself as a pioneer in the worldwide medical…
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Global MarketRegulatoryU.S FDA
Sol-Gel Technologies and Galderma’s EPSOLAY® Scores US FDA Approval
by adminby adminSummary: EPSOLAY (benzoyl peroxide, cream, 5%) utilizes Sol-Gel’s proprietary microencapsulation technology for the treatment of inflammatory lesions of rosacea and is patent…
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Covid DrugsGileadRegulatoryU.S FDA
Gilead’s Veklury Becomes the First FDA-approved COVID-19 Treatment for Infants
by adminby adminSummary : The first treatment for COVID-19 in young children has been approved by the US Food and Drug Administration. In this…
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RegulatoryU.S FDA
Alymsys® (Bevacizumab-maly), a Biosimilar of Bevacizumab developed by mAbxience, has been Approved by the FDA.
by adminby adminSummary : ALYMSYS® was developed by mAbxience, a global biotech company with over a decade of experience in the development, manufacture, and commercialization…
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Covid DrugsRegulatoryU.S FDA
The First COVID-19 Diagnostic Test Employing Breath Samples has been Approved by the US Food and Drug Administration.
by adminby adminSummary : Food and Drug Administration on Apr 14 issued an emergency use authorization It said is the first device that can…
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RegulatoryU.S FDA
First Generic of Symbicort (Budesonide and Formoterol Fumarate Dihydrate) Receives FDA Approval
by adminby adminSummary : The U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol to…
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RegulatoryU.S FDA
Telix Granted FDA Orphan Drug Designation for Bone Marrow Conditioning Treatment
by adminby adminSummary : Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States Food and Drug Administration (FDA) has…