FDA News

FDA Accepts Puma’s sNDA for Neratinib for Treatment of Patients with HER2-Positive Metastatic Breast Cancer

LOS ANGELES–(BUSINESS WIRE)–Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) for neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed two or …

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FDA Grants Merck KGaA’s Tepotinib Breakthrough Therapy Designation for Patients with Metastatic NSCLC with METex14 Skipping Alterations

DARMSTADT, Germany, Sept. 11, 2019 /PRNewswire/– Merck KGaA, Darmstadt, Germany, a leading science and technology company, which operates its biopharmaceutical business as EMD Serono in the US and Canada, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the investigational targeted therapy tepotinib* …

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FDA Approves Xeris Pharmaceuticals’ Gvoke Injection for the Treatment of Severe Hypoglycemia

CHICAGO–(BUSINESS WIRE)–Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, announced today that it has received regulatory approval from the U.S. Food and Drug Administration (FDA) for GVOKE™ (glucagon) injection, its ready-to-use, room-temperature stable liquid …

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FDA Approves Ofev, the First and Only Therapy to Slow the Rate of Decline in Pulmonary Function in Patients with Sclerosis-Associated ILD

Ridgefield, Conn., September 06, 2019 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved Ofev® (nintedanib) as the first and only medicine to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Ofev is already approved in the …

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FDA Accepts Allergan’s BLA for Abicipar Pegol in Patients with Wet Age-Related Macular Degeneration

DUBLIN, Sept. 9, 2019 /PRNewswire/ — Allergan plc (NYSE: AGN), a leading global pharmaceutical company with a heritage of more than 70 years in eye care, and Molecular Partners (SIX: MOLN), a clinical-stage biotechnology company developing a new class of drugs known as DARPin® platform, today announced that the U.S. …

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Adaptimmune’s SPEAR T-cells Targeting MAGE-A4 Granted Orphan Drug Designation from the FDA for Treatment of Soft Tissue Sarcomas

PHILADELPHIA and OXFORDSHIRE, United Kingdom, Sept. 09, 2019 (GLOBE NEWSWIRE) — Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to SPEAR T-cells targeting MAGE-A4 (Adaptimmune’s ADP-A2M4 program) for the …

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FDA Grants Orphan Drug Designation to Acceleron’s Sotatercept for Treatment of Pulmonary Arterial Hypertension

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 sotatercept for the treatment of patients with pulmonary …

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ProQR Receives Fast Track Designation from FDA for QR-1123 for Autosomal Dominant Retinitis Pigmentosa

LEIDEN, Netherlands and CAMBRIDGE, Mass., Sept. 09, 2019 (GLOBE NEWSWIRE) — ProQR Therapeutics N.V. (Nasdaq:PRQR), a company dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe genetic rare diseases, today announced that it received Fast Track designation from the Food and Drug Administration (FDA) for QR-1123. QR-1123 is a …

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FDA Grants Breakthrough Device Designation to Prescient Metabiomics’ LifeKit Prevent Test for Early Detection of Colon Polyps and Colon Cancer

CARLSBAD, Calif., Sept. 4, 2019 /PRNewswire/ — Prescient Metabiomics, a privately held company and a subsidiary of Prescient Medicine Holdings, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted the company’s submission for Breakthrough Device designation to its LifeKit® Prevent Colorectal Neoplasia Test. This Breakthrough Device designation …

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FDA Grants Regenerative Medicine Advanced Therapy Designation to Magenta’s MGTA-456 for Treatment of Inherited Metabolic Disorders

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplant to more patients, today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advance Therapy (RMAT) designation for MGTA-456, a one-time cell therapy for the treatment …

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