Summary : The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) to Gilead Sciences rejecting its New Drug Application…
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Pediatric
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GileadGlobal MarketPatentsRegulatory
Gilead’s Strong Financials Marred by $1.25B ViiV Patent Settlement
by adminby adminSummary : This week, Gilead Sciences took a $1.25 billion hit after reaching a settlement with ViiV Healthcare on a patent dispute…
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Agrochemicals
BioMarin`s VOXZOGO (Vosoritide) becomes the First U.S.FDA-approved Drug Therapy for Dwarfism.
by adminby adminSynopsis: BioMarin Pharmaceutical announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to VOXZOGO™ (Vosoritide) for Injection, indicated…
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Active Pharmaceutical Ingredients (API)BictegravirEmtricitabineTenofovir Alafenamide
USFDA Approves Expanded Indication of Gilead’s Biktarvy for Treatment of HIV-1 in Pediatric Populations
by adminby adminKeypoints FDA Approves Low-Dose Tablet for HIV Treatment in Virologically Suppressed Children Weighing at Least 14 kg. Biktarvy Provides an Effective Treatment…