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FDA Approves Lilly’s Reyvow, the First and Only Medicine in a New Class of Acute Treatment for Migraine

INDIANAPOLIS, Oct. 11, 2019 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved REYVOW™ (lasmiditan) an oral medication for the acute treatment of migraine, with or without aura, in adults. REYVOW has a unique mechanism of action and is the first and only FDA-approved medicine in …

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FDA Grants Breakthrough Therapy Designation for Chronic Fibrosing ILDs with a Progressive Phenotype

RIDGEFIELD, Conn., Oct. 10, 2019 /PRNewswire/ — Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to Ofev® (nintedanib), which is currently under FDA review for the treatment of people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Regulatory applications have been …

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FDA Approves Clinuvel’s Scenesse, the First Treatment for a Rare Genetic Metabolic Disorder that Causes Light Intolerance

MELBOURNE, Australia, Oct. 08, 2019 (GLOBE NEWSWIRE) — The US Food and Drug Administration (FDA) has approved a new drug as the first ever treatment for a rare genetic metabolic disorder which causes absolute intolerance to light. SCENESSE® (afamelanotide 16mg), the first drug developed by Australian biopharmaceutical company CLINUVEL, has …

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FDA Approves Octapharma’s Wilate for the Treatment of Adults and Adolescents with Hemophilia A

HOBOKEN, N.J.–(BUSINESS WIRE)–Octapharma USA today announced the U.S. Food and Drug Administration (FDA) has approved WILATE® for treatment of adults and adolescents with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and on demand treatment and control of bleeding episodes. WILATE® is a human plasma-derived, sterile, purified, double virus inactivated von Willebrand …

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FDA Approves Novartis’ Beovu Injection for Treatment of Wet Age-Related Macular Degeneration

Basel, October 8, 2019 — Novartis today announced that the U.S. Food and Drug Administration (FDA) approved Beovu® (brolucizumab) injection, also known as RTH258 for the treatment of wet age-related macular degeneration (AMD)[1]. Beovu is the first FDA approved anti-VEGF to offer both greater fluid resolution versus aflibercept and the ability …

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Medtronic Receives FDA Breakthrough Device Designation for Developing Stent Graft System to Treat Thoracoabdominal Aortic Aneurysm

DUBLIN, Oct. 08, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its Valiant® TAAA Stent Graft System for minimally invasive repair of thoracoabdominal aortic aneurysm (TAAA). A TAAA is a complex condition causing a bulging of …

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Janssen Seeks FDA Approval of Stelara for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis

SPRING HOUSE, Pa., Oct. 7, 2019  — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric (ages 6-11) patients with moderate to severe plaque psoriasis …

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FDA Grants Fast Track Designation to Mereo’s Navicixizumab for the Treatment of Heavily Pretreated Ovarian Cancer

LONDON and REDWOOD CITY, Calif., Oct. 07, 2019 (GLOBE NEWSWIRE) — Mereo BioPharma Group plc (NASDAQ: MREO, AIM: MPH), “Mereo” or the “Company” or the “Group,” a clinical stage biopharmaceutical company focused on rare diseases, today announces that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation …

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FDA Approves Gilead’s Descovy for HIV Pre-Exposure Prophylaxis

FOSTER CITY, Calif.–(BUSINESS WIRE)–Oct. 3, 2019– Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved a pre-exposure prophylaxis (PrEP) indication for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF). Descovy for PrEP™ is indicated to reduce the risk of sexually acquired HIV-1 infection in …

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GSK Submits sNDA to the FDA for Trelegy Ellipta for Use in Patients With Asthma

LONDON–(BUSINESS WIRE)–GlaxoSmithKline plc (GSK) and Innoviva, Inc. (INVA) today announced the filing of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) seeking an additional indication for the use of once-daily, single-inhaler triple therapy, Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol or FF/UMEC/VI), for the treatment of asthma …

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