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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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
US FDA Grants Orphan Drug Designation to Gracell’s FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T cell therapy, GC012F to Treat Multiple Myeloma.
by adminby adminSynopsis: The FDA granted orphan drug designation to GC012F, a novel chimeric antigen receptor T-cell therapy for the treatment of relapsed or…
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Agrochemicals
FDA Grants AppliedVR Approval for First Virtual Reality Therapeutic to Treat Chronic Low Back Pain.
by adminby adminSUMMARY: The U.S. Food and Drug Administration today authorized marketing of EaseVRx, a prescription-use immersive virtual reality (VR) system that uses cognitive…
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Diroximel Fumarate
The European Commission Grants Marketing Authorization for VUMERITY® (Diroximel Fumarate) as Oral Treatment for Relapsing-Remitting Multiple Sclerosis.
by adminby adminSYNOPSIS: VUMERITY is a next-generation oral fumarate treatment for people with relapsing-remitting MS with established efficacy and well-characterized safety, building on Biogen’s…
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Active Pharmaceutical Ingredients (API)Ataluren
ANVISA grants expanded Approval to PTC’s Translarna label to include Ambulatory Patients as young as 2 years old in Brazil.
by adminby adminKeypoints: PTC Therapeutics, Inc. announced that the Brazilian National Health Surveillance Agency has approved the expansion of the indication of Translarna (Ataluren)…
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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…