Summary : Amvuttra (vutrisiran) from Alnylam Pharmaceuticals has been licenced by the US Food and Drug Administration for the treatment of hereditary…
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U.S FDA
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RegulatoryRocheU.S FDA
FDA Approves Roche’s Evrysdi for Use in Babies under Two Months with Spinal Muscular Atrophy (SMA)
by adminby adminSummary : Roche announced that the U.S. Food and Drug Administration (FDA) has approved a label extension for Evrysdi® (risdiplam) to include…
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Amgen Inc.RegulatoryU.S FDA
FDA Approves RIABNI™ (Rituximab-arrx), a Biosimilar to Rituxan® (Rituximab), for adults with moderate to severe Rheumatoid Arthritis
by adminby adminSummary : Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved RIABNI™ (rituximab-arrx), a biosimilar to Rituxan®, in…
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Global MarketRegulatorySanofi Inc.U.S FDA
FDA Approves Dupixent®(Dupilumab) as First Biologic Medicine for Children Aged 6 Months to 5 Years with Moderate-to-Severe Atopic Dermatitis
by adminby adminSummary : Children treated with Dupixent and topical corticosteroids (TCS) achieved clearer skin, experienced significantly improved overall disease severity and significantly reduced…
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GskRegulatoryU.S FDA
GSK Announces US FDA Approval of Priorix For the Prevention of Measles, Mumps and Rubella .
by adminby adminSummary : US Food and Drug Administration (FDA) has approved Priorix (Measles, Mumps and Rubella Vaccine, Live) for active immunisation for the prevention of…
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Summary: Lipocine Inc. , a clinical-stage biopharmaceutical company focused on developing innovative products for neuroendocrine and metabolic disorders, announced today that Antares…
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RegulatoryU.S FDA
TherapeuticsMD Receives U.S. Receives US Food and Drug Administration (FDA) Approval for the Supplemental New Drug Application (sNDA) for ANNOVERA
by adminby adminSummary : ANNOVERA is the only FDA-approved procedure-free, long-lasting, reversible birth control – -With this approval, the Company expects a significant reduction…
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CompaniesEli LillyRegulatoryU.S FDA
Eli Lilly Gets FDA Approval for Diabetic Drug Tirzepatide
by adminby adminSummary : The Food and Drug Administration (FDA) has approved a novel first-in-class drug to treat type 2 diabetes. The drug is…
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Daiichi SankyoRegulatoryU.S FDA
FDA Grants Regular Approval to Fam-Trastuzumab Deruxtecan-Nxki(Enhertu) for Breast Cancer
by adminby adminSummary: Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic HER2-positive breast cancer…
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RegulatoryU.S FDA
Phathom Pharmaceuticals Announces FDA Approval of VOQUEZNA™ TRIPLE PAK™ (Vonoprazan, Amoxicillin, Clarithromycin) and VOQUEZNA™ DUAL PAK™ (Vonoprazan, Amoxicillin) for the Treatment of H. pylori Infection in Adults
by adminby adminSummary : The FDA approved two vonoprazan-based regimens, one with amoxicillin and clarithromycin (Voquezna Triple Pak) and one with amoxicillin (Voquezna Dual…