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Lilly’s Cyramza Becomes First FDA-Approved Biomarker-Driven Therapy in Patients with Hepatocellular Carcinoma

INDIANAPOLIS, May 13, 2019 /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), as a single agent, for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha-fetoprotein (AFP) of ≥400 ng/mL and have been treated with sorafenib. …

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Celgene’s Pomalyst Granted Breakthrough Therapy Designation from the FDA for HIV-Positive and Negative Kaposi Sarcoma

SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to POMALYST® (pomalidomide) for the treatment of patients with human immunodeficiency virus (HIV)-positive Kaposi sarcoma who have previously received systemic chemotherapy, as well as patients with HIV‐negative Kaposi’s sarcoma. Kaposi …

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FDA Grants Orphan Drug Designation to Poseida’s P-BCMA-101 for the Treatment of Multiple Myeloma

SAN DIEGO, May 13, 2019 (GLOBE NEWSWIRE) — Poseida Therapeutics Inc., a clinical-stage biopharmaceutical company leveraging proprietary non-viral gene engineering technologies to create life-saving therapeutics, today announced the United States Food and Drug Administration (FDA) has granted orphan drug designation to P-BCMA-101 for the treatment of relapsed and/or refractory multiple …

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Statement from Acting FDA Commissioner Sharpless on Policy Advancements to Bring Interchangeable Biosimilars to Market

The U.S. Food and Drug Administration plays an important role in helping to address the high cost of medicines through the development of science-based policies that can improve competition and patient access to safe and effective, high-quality and lower cost generic drugs, biosimilars and interchangeable biologics. Today, the FDA is …

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Sunovion and PsychoGenics Announce that SEP-363856 Received FDA Breakthrough Therapy Designation for Treatment of Schizophrenia

MARLBOROUGH, Mass. & PARAMUS, N.J.–(BUSINESS WIRE)–Sunovion Pharmaceuticals Inc. (Sunovion) and PsychoGenics Inc. (PsychoGenics), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for SEP-363856, a novel agent for the treatment of people with schizophrenia. Breakthrough Therapy Designation is intended to expedite the development and review of drugs …

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FDA Approves First Treatment for Children with Lambert-Eaton Myasthenic Syndrome, a Rare Autoimmune Disorder

The U.S. Food and Drug Administration today approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to less than 17 years of age. This is the first FDA approval of a treatment specifically for pediatric patients with LEMS. The only other treatment approved for …

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FDA Grants Breakthrough Device Designation to Natera’s Signatera Test

SAN CARLOS, Calif., May 6, 2019 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA) today announced that the U.S. Food and Drug Administration (FDA) has granted “Breakthrough Device” designation for its Signatera™ test for use in the post-surgical detection and quantification of circulating tumor DNA (ctDNA) in the blood of patients previously …

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FDA Approves Vyndaqel and Vyndamax for Patients with Transthyretin Amyloid Cardiomyopathy, a Rare and Fatal Disease

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved both VYNDAQEL® (tafamidis meglumine) and VYNDAMAX™ (tafamidis) for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. VYNDAQEL and VYNDAMAX are two oral …

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FDA Grants Zynerba’s Zygel Fast Track Designation for the Treatment of Behavioral Symptoms Associated with Fragile X Syndrome

DEVON, Pa., May 06, 2019 (GLOBE NEWSWIRE) — Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the Company’s lead development candidate Zygel™ (ZYN002 CBD …

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FDA Approves Genentech’s Kadcyla for Adjuvant Treatment of HER2-Positive Early Breast Cancer with Residual Invasive Disease After Neoadjuvant Treatment

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 Kadcyla® (ado-trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant …

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