FDA Approves Veklury (remdesivir) to Treat COVID-19 in People With Mild to Severe Hepatic Impairment With no Dose Adjustment
FOSTER CITY, Calif.--(BUSINESS WIRE) August 24, 2023 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for the use of Veklury®... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 24, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Tyruko (natalizumab-sztn), a Biosimilar to Tysabri
August 24, 2023 -- The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). Tyruko, like... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 24, 2023 Category: Drugs & Pharmacology Source Type: news
U.S. FDA Approves Abrysvo, Pfizer ’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in Infants Through Active Immunization of Pregnant Individuals 32-36 Weeks of Gestational Age
NEW YORK--(BUSINESS WIRE) August 21, 2023 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Abrysvo™ (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 21, 2023 Category: Drugs & Pharmacology Source Type: news
Neurocrine Biosciences Announces FDA Approval of Ingrezza (valbenazine) Capsules for the Treatment of Chorea Associated With Huntington's Disease
SAN DIEGO, Aug. 18, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration (FDA) has approved Ingrezza® (valbenazine) capsules for the treatment of adults with chorea associated... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 18, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Eylea HD (aflibercept) Injection 8 mg for Treatment of Wet Age-related Macular Degeneration (wAMD), Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR)
TARRYTOWN, N.Y., Aug. 18, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Eylea HD (aflibercept) Injection 8 mg for the treatment of patients with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 18, 2023 Category: Drugs & Pharmacology Source Type: news
Eylea HD (aflibercept) Injection 8 mg Approved by FDA for Treatment of Wet Age-related Macular Degeneration (wAMD), Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR)
TARRYTOWN, N.Y., Aug. 18, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Eylea HD (aflibercept) Injection 8 mg for the treatment of patients with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 18, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Veopoz (pozelimab-bbfg) as the First Treatment for Children and Adults with CHAPLE Disease
TARRYTOWN, N.Y., Aug. 18, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has approved Veopoz™ (pozelimab-bbfg) for the treatment of adult and pediatric... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 18, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Sohonos (palovarotene) for the Treatment of Fibrodysplasia Ossificans Progressiva
PARIS, FRANCE, 16 August 2023– Ipsen (Euronext: IPN; ADR: IPSEY) announced today approval by the U.S. Food and Drug Administration (FDA) of Sohonos™ (palovarotene) capsules as a retinoid indicated for the reduction in volume of new... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 16, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves First Therapeutic Indication for Revance ’s Daxxify (daxibotulinumtoxinA-lanm) for Injection for the Treatment of Cervical Dystonia
Provides Revance entry into the $2.5 billion U.S. therapeutic neuromodulator market.1
Approval expands the Daxxify® label to include efficacy data over the 52-week ASPEN repeat dose clinical study.
Daxxify® for cervical dystonia is the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 15, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Grants Accelerated Approval for Elrexfio (elranatamab-bcmm) for Relapsed or Refractory Multiple Myeloma
The approval of Elrexfio (elranatamab-bcmm) is based on clinically meaningful response rates and duration of response from Phase 2 MagnetisMM-3 study
Elrexfio is the first off-the-shelf (ready-to-use) fixed-dose subcutaneous BCMA-directed agent... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 14, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Hepzato Kit (melphalan) Hepatic Delivery System for the Treatment of Unresectable Hepatic-Dominant Metastatic Uveal Melanoma
NEW YORK, Aug. 14, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced that today the US Food and Drug Administration... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 14, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Akeega (niraparib and abiraterone acetate) for the Treatment of Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer
HORSHAM, Pa., August 11, 2023– The Janssen Pharmaceutical Companies of Johnson& Johnson today announced that the U.S. Food& Drug Administration (FDA) has approved Akeega™ (niraparib and abiraterone acetate), the first-and-only... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 11, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Talvey (talquetamab-tgvs), a First-in-Class Bispecific Therapy for the Treatment of Patients with Heavily Pretreated Multiple Myeloma
HORSHAM, Pa., Aug. 10, 2023– The Janssen Pharmaceutical Companies of Johnson& Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Talvey™ (talquetamab-tgvs), a first-in-class... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 10, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Grants Regular Approval for Gavreto (pralsetinib) for Non-Small Cell Lung Cancer with RET Gene Fusions
On August 9, 2023, the Food and Drug Administration granted regular approval to pralsetinib (Gavreto, Genentech, Inc.) for adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 9, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Izervay (avacincaptad pegol) Intravitreal Solution for the Treatment for Geographic Atrophy
TOKYO, Aug. 5, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, " Astellas " ), today announced the U.S. Food and Drug Administration (FDA) approved Izervay™ (avacincaptad pegol intravitreal solution) for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 5, 2023 Category: Drugs & Pharmacology Source Type: news
