FDA News

FDA Approves First-Ever Dispersible Tablet Formulation of Tivicay PD, a Once-Daily Treatment for Children Living with HIV

LONDON–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Tivicay PD (dolutegravir) tablets for oral suspension, which are used in combination with other antiretroviral agents for the treatment …

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FDA Approves Viela Bio’s Uplizna for the Treatment of Neuromyelitis Optica Spectrum Disorder

GAITHERSBURG, Md., June 11, 2020 (GLOBE NEWSWIRE) — Viela Bio (Nasdaq:VIE) today announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNATM (inebilizumab-cdon) for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-AQP4 antibody positive as a twice-a-year maintenance regimen following initial doses. Approximately 80%1 of …

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FDA Approves Updated Novartis Beovu Label to Include Additional Safety Information

Basel, June 11, 2020 — Novartis announced today that the US Food and Drug Administration (FDA) has approved a label update for Beovu® (brolucizumab) to include additional safety information regarding retinal vasculitis and retinal vascular occlusion1. This approval follows Novartis’ announcement that it would pursue worldwide label updates after a review and further characterization …

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FDA Approves Pfizer’s Oncology Supportive Care Biosimilar, NYVEPRIA (pegfilgrastim-apgf)

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved NYVEPRIA™ (pegfilgrastim-apgf), a biosimilar to Neulasta® (pegfilgrastim).1 NYVEPRIA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a …

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FDA Approves Opdivo for Treatment of Patients with Advanced Esophageal Squamous Cell Carcinoma

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo® (nivolumab) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.1 This application was granted Priority Review Designation by the FDA, …

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Illumina Receives First FDA Emergency Use Authorization for a Sequencing-Based COVID-19 Diagnostic Test

SAN DIEGO–(BUSINESS WIRE)–Illumina, Inc. (NASDAQ: ILMN) is paving the way for large-scale, next-generation sequencing-based (NGS) COVID-19 testing. Today, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Illumina COVIDSeq™ Test, a high-throughput, sequencing-based, in vitro diagnostic (IVD) workflow enabling the detection of SARS-CoV-2. The …

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Insmed Receives FDA Breakthrough Therapy Designation for Brensocatib in Patients with Non-Cystic Fibrosis Bronchiectasis

BRIDGEWATER, N.J., June 8, 2020 /PRNewswire/ — Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation for brensocatib (formerly known as INS1007) for …

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FDA Approves Merck’s Recarbrio for Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia

ENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for RECARBRIO™ (imipenem, cilastatin, and relebactam) for the treatment of patients 18 years of age and older with …

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FDA Grants Fast Track Designation to TVAC Biomedical’s Vaccine-Enhanced Adoptive T-Cell Therapy for Treatment of Glioblastoma Multiforme

OLATHE, Kan., June 4, 2020 /PRNewswire/ — TVAX Biomedical announced today receipt of Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the use of its vaccine-enhanced adoptive T cell therapy (VACT) for treatment of glioblastoma multiforme, a deadly form of brain cancer.  “We are very pleased …

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FDA Grants Emergency Use Authorization to Roche’s Elecsys IL-6 Test to Identify Patients at High Risk of Severe Inflammatory Response

Basel, 04 June 2020  – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the Elecsys® IL-6 test. This test measures levels of the biomarker interleukin 6 (IL-6) and can be used to help identify …

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