FDA News

FDA Extends Review for Novartis’ sBLA for Ofatumumab in Patients with Relapsing Multiple Sclerosis

Basel, June 2, 2020 —  Novartis today announced that it has received notice from the US Food and Drug Administration (FDA) that the agency has extended its review of the Supplemental Biologics License Application (sBLA) for ofatumumab (OMB 157), a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis. Regulatory …

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Lilly’s Taltz is the First IL-17A Antagonist to Receive FDA Approval for the Treatment of Non-Radiographic Axial Spondyloarthritis

INDIANAPOLIS, June 1, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Taltz® (ixekizumab) injection 80 mg/mL for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation. Another first-in-class milestone for the treatment, …

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FDA Accepts Shionogi’s sNDA with Priority Review for Fetroja for Treatment of Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia

OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE)–Shionogi & Co., Ltd. (hereafter “Shionogi”) today announced the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for FETROJA® (cefiderocol) and granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) date of September 27, 2020. …

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Siemens Healthineers Receives FDA Emergency Use Authorization for its SARS-CoV-2 Total Antibody Test that Delivers Superior Clinical Performance

TARRYTOWN, N.Y.–(BUSINESS WIRE)–Siemens Healthineers announced today the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its laboratory-based total antibody test to detect the presence of SARS-CoV-2 antibodies including IgM and IgG in blood. Test data demonstrated 100 percent sensitivity2 and 99.8 percent specificity. The total antibody …

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Lilly’s Cyramza Receives FDA Approval as First-Line Treatment for Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

INDIANAPOLIS, May 29, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved CYRAMZA® (ramucirumab injection, 10 mg/mL solution), in combination with erlotinib, for the first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or …

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FDA Approves Genentech’s Tecentriq in Combination with Avastin for Treatment of Advanced Hepatocellular Carcinoma

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of people with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior …

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FDA Approves First Oral Medication for the Management of Heavy Menstrual Bleeding Due to Uterine Fibroids in Pre-menopausal Women

NORTH CHICAGO, Ill., May 29, 2020 /PRNewswire/ — AbbVie (NYSE: ABBV), in cooperation with Neurocrine Biosciences, Inc. (Nasdaq: NBIX), announced that the U.S. Food and Drug Administration (FDA) approved ORIAHNN™ (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules), with a treatment duration of up to 24 months.2 ORIAHNN is the first FDA-approved non-surgical, oral medication option for …

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FDA Approves Lilly’s Tauvid for Injection for Use in Patients Being Evaluated for Alzheimer’s Disease

INDIANAPOLIS, May 28, 2020 /PRNewswire/ — TAUVID™, a radioactive diagnostic agent, has been approved by the FDA for positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD).1 A neuropathological …

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Cardiff Oncology Announces FDA Grants Fast Track Designation to Onvansertib for Second-Line Treatment of KRAS-Mutated Colorectal Cancer

SAN DIEGO, May 28, 2020 /PRNewswire/ — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, Zytiga®-resistant prostate cancer and leukemia, today announced that the U.S. Food and Drug Administration (FDA) …

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Protalix and Chiesi Submit BLA to the FDA for Pegunigalsidase Alfa for the Treatment of Fabry Disease

CARMIEL, Israel, May 28, 2020 /PRNewswire/ —  Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, or the Company, together with its development and commercialization partner Chiesi …

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