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FDA Grants Genentech’s Tecentriq in Combination With Abraxane Accelerated Approval for PD-L1-Positive, Metastatic TNBC

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tecentriq®(atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the treatment of adults with unresectable locally advanced or …

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FDA Approves Janssen’s Spravato CIII Nasal Spray Medication for Treatment-Resistant Depression

TITUSVILLE, N.J., – (March 5, 2019) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved SPRAVATO™ (esketamine) CIII nasal spray for use in conjunction with an oral antidepressant in adults with treatment-resistant depression (TRD).1 People who are currently struggling with major …

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Celgene’s Fedratinib Granted Priority Review by the FDA for Treatment of Myelofibrosis

SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ:CELG) today announced the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for fedratinib and granted a Priority Review. Fedratinib is a highly selective JAK2 inhibitor intended for the treatment of patients with myelofibrosis, a serious bone marrow disorder that …

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Acceleron Receives FDA Orphan Drug Designation for ACE-083 in Charcot-Marie-Tooth Disease

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Acceleron Pharma Inc. (NASDAQ:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug designation to ACE-083, the Company’s locally-acting “Myostatin+” muscle agent, for …

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FDA Grants Priority Review Designation for Lilly’s Emgality Injection for Preventive Treatment of Episodic Cluster Headache

INDIANAPOLIS, March 5, 2019 /PRNewswire/ –Eli Lilly and Company(NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for its supplemental Biologics License Application (sBLA) for Emgality® (galcanezumab-gnlm) injection for the preventive treatment of episodic cluster headache in adults. Priority Review aims to expedite the review of applications for drugs …

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FDA Approves Herceptin Hylecta for Subcutaneous Injection in Certain HER2-Positive Breast Cancers

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has approved Herceptin Hylecta™ (trastuzumab and hyaluronidase-oysk) for subcutaneous (under the skin) injection for the treatment of certain people with HER2-positive early breast cancer (node-positive, …

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FDA Grants Breakthrough Device Designation to T2 Biosystems’ T2Resistance Panel

LEXINGTON, Mass., Feb. 27, 2019 (GLOBE NEWSWIRE) — The FDA has granted T2 Biosystems, Inc. (NASDAQ:TTOO) “Breakthrough Device” designation for the T2Resistance Panel, a diagnostic panel that can detect 13 resistance genes from both gram-positive and gram-negative pathogens from a single patient blood sample, without the wait for blood culture. The 13 …

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FDA Approves Janssen’s Tremfya One-Press Patient-Controlled Injector for Adults with Moderate-to-Severe Plaque Psoriasis

HORSHAM, PENNSYLVANIA, February 27, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® One-Press, a single-dose, patient-controlled injector for adults with moderate-to-severe plaque psoriasis. TREMFYA® (guselkumab) is the first FDA-approved medication of its kind to offer the One-Press patient-controlled …

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Spero Therapeutics Receives QIDP Designation from the FDA for the Development of SPR720 in Non-Tuberculous Mycobacterial and Lung Infections

CAMBRIDGE, Mass., Feb. 26, 2019 (GLOBE NEWSWIRE) — Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant bacterial infections, announced today that SPR720, an orally administered antimicrobial agent being developed for the treatment of non-tuberculous mycobacterial (NTM) infections, has been granted Qualified …

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FDA Approves Taiho Oncology’s Lonsurf for Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

PRINCETON, N.J., February 25, 2019 – Taiho Oncology, Inc. today announced that the United States Food and Drug Administration (FDA) has approved LONSURF® as a treatment for adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, …

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