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Bayer Announces the FDA Accepted the NDA and Granted Priority Review to Darolutamide for Treatment of Non-Metastatic Castration-resistant Prostate Cancer

WHIPPANY, N.J., April 29, 2019 /PRNewswire/ — Bayer today announced the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted Priority Review to darolutamide for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). The NDA and Priority Review status were based on data from …

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ViiV Submits NDA to the FDA for the First Monthly, Injectable, Two-Drug Regimen of Cabotegravir and Rilpivirine for Treatment of HIV

LONDON–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for the investigational, monthly, injectable, two-drug regimen of ViiV Healthcare’s cabotegravir and Janssen’s …

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FDA Approves PCSK9 Inhibitor Praluent to Reduce Risk of Heart Attack, Stroke, and Unstable Angina Requiring Hospitalization

Regeneron Pharmaceuticals, Inc. (NASDAQ:  REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Praluent® (alirocumab) to reduce the risk of heart attack, stroke and unstable angina requiring hospitalization in adults with established cardiovascular (CV) disease. “Heart disease accounts for one quarter of all American …

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FDA Approves GSK’s Benlysta for Intravenous Use in Children with Lupus Aged Five Years and Above

LONDON and PHILADELPHIA, April 26, 2019 /PRNewswire/ — GSK today announced that the US Food and Drug Administration (FDA) has approved, under priority review, the use of the intravenous (IV) formulation of Benlysta (belimumab), a B-lymphocyte stimulator (BLyS)-specific inhibitor, in children with lupus from as young as five years of …

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FDA Approves Convenient Single-Vial Dosing for CSL Behring’s Zemaira for Patients with Alpha 1 Antitrypsin Deficiency

KING OF PRUSSIA, Pa., April 25, 2019 /PRNewswire/ — Global biotherapeutics leader CSL Behring today announced that the US Food and Drug Administration (FDA) has approved 4- and 5-gram vial sizes for ZEMAIRA® [Alpha1-Proteinase Inhibitor (Human)], its therapy for treating Alpha 1 Antitrypsin Deficiency (Alpha 1).  This approval is significant …

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FDA Approves AbbVie’s Skyrizi for Treatment of Moderate-to-Severe Plaque Psoriasis

NORTH CHICAGO, Ill., April 23, 2019 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved SKYRIZI™ (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.3 In …

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FDA Grants Breakthrough Therapy Designation to La Jolla Pharmaceutical’s Investigational Treatment for Severe Malaria

SAN DIEGO, April 24, 2019 (GLOBE NEWSWIRE) — La Jolla Pharmaceutical Company (Nasdaq: LJPC), a leader in the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for …

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Autolus Therapeutics Receives FDA Orphan Drug Designation for AUTO3 for Treatment of Acute Lymphoblastic Leukemia

LONDON, April 23, 2019 (GLOBE NEWSWIRE) — Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer, announced that the United States Food and Drug Administration (FDA) has granted orphan drug designation to autologous enriched T-cells genetically modified with a retroviral …

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FDA Approves Merck’s Keytruda in Combination with Inlyta as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma …

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FDA Permits Marketing of First Medical Device for Treatment of Attention Deficit Hyperactivity Disorder

The U.S. Food and Drug Administration today permitted marketing of the first medical device to treat attention deficit hyperactivity disorder (ADHD). The prescription-only device, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, is indicated for patients ages 7 to12 years old who are not currently taking prescription ADHD medication …

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