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Teva’s Cinqair Granted FDA Approval for Treatment of Severe Asthma

JERUSALEM–(BUSINESS WIRE)–Mar. 23, 2016– Teva Pharmaceutical Industries Ltd.(NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration(FDA) has approved CINQAIR® (reslizumab) Injection, an interleukin 5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with …

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FDA Approves Lilly’s Taltz for Treatment of Psoriasis

The U.S. Food and Drug Administration today approved Taltz (ixekizumab) to treat adults with moderate-to-severe plaque psoriasis. Psoriasis is a skin condition that causes patches of skin redness and flaking. Psoriasis is an autoimmune disorder that occurs more commonly in patients with a family history of the disease, and most …

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Vermillion’s Ovarian Cancer Test Overa Receives FDA Clearance

AUSTIN, Texas, March 21, 2016 /PRNewswire/ — Vermillion, Inc. (NASDAQ: VRML), a bio-analytical solutions company focused on gynecologic disease, announced today the receipt of 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for the successor to Vermillion’s OVA1® test for determining ovarian cancer risk in conjunction with …

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FDA Approves Anthim Injection for Treatment of Inhalational Anthrax

On Friday, March 18, the U.S. Food and Drug Administration approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs. Anthim is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate. Inhalational anthrax is a rare disease that can occur …

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FDA Approves Bayer’s Long-Acting Hemophilia Drug

WHIPPANY, N.J., March 17, 2016 /PRNewswire/ — The U.S. Food and Drug Administration has approved Bayer’s KOVALTRY®Antihemophilic Factor (Recombinant), an unmodified, full-length factor VIII compound for the treatment of hemophilia A in children and adults. The approval is based on results from the LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia …

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FDA Approves Spectrum Pharmaceuticals’ Evomela for Injection

HENDERSON, Nev.–(BUSINESS WIRE)– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted approval of EVOMELA for use in two indications: 1) use as a …

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FDA Grants Genentech’s Immunotherapy Priority Review for Advanced Bladder Cancer

South San Francisco, CA — March 14, 2016 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of …

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Sarepta Announces FDA Advisory Committee Review Date for its DMD Drug Eteplirsen

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review Sarepta’s New Drug Application (NDA) for eteplirsen on April 25, 2016. The Prescription Drug User Fee …

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ProNAi’s DLBCL Candidate Awarded FDA Orphan Drug Designation

VANCOUVER, March 14, 2016 /PRNewswire/ – ProNAi Therapeutics, Inc. (NASDAQ: DNAI), a clinical-stage oncology company advancing novel therapeutics for patients with cancer and hematological diseases, today announced that its oncology drug candidate PNT2258 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of diffuse …

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