FDA Approval The latest news regarding FDA applications, processes, and approval. This section contains releases regarding the Food and Drug Administration’s consideration of new products, drugs, therapies and treatments. Find announcements covering every stage of the FDA application process, from filing to eventual approval, including appeals, resubmissions, and safety alerts.

Latest

Apr 24, 2020, 15:38 ET BGI Expands EUA Label for SARS-CoV-2 RT-PCR Test with MGI Automated Extraction Methods and Additional PCR Systems

BGI Genomics. Co. Ltd. (SZSE:300676) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for expanding its ...


Apr 23, 2020, 08:04 ET U.S. FDA grants orphan drug designation to AmideBio's glucagon analog for the treatment of congenital hyperinsulinism

AmideBio, LLC, a privately held biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) Office of Orphan Products...


Apr 22, 2020, 20:00 ET Samsung Biologics and ImmuneOncia Therapeutics Inc. Development and Manufacturing Agreement Accomplishes IND Clearance of IMC-002 (anti-CD47 antibody)

Samsung Biologics (207940.KS) and ImmuneOncia Therapeutics Inc. announced the successful FDA IND approval of IMC-002 under a development and...


Apr 22, 2020, 13:37 ET FDA Approves New Therapy for Triple Negative Breast Cancer That Has Spread, Not Responded to Other Treatments

Today, the U.S. Food and Drug Administration granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult...


Apr 22, 2020, 08:17 ET Bimini Health Tech Announces FDA 510(k) Clearance for Dermapose Refresh Fat Transfer Technology

Bimini Health Tech announced today it received FDA 510(k) clearance (K193363) for its novel Dermapose Refresh? Syringe-Based, Fat Transfer Technology....


Apr 22, 2020, 02:30 ET Amerikaanse FDA Verleent CytoSorb? Goedkeuring voor Noodgebruik bij Pati?nten met COVID-19

CytoSorbents Corporation (NASDAQ: CTSO), een leider op het gebied van immunotherapie in kritische zorg dat zijn CytoSorb? bloedzuiveringstechnologie...


Apr 22, 2020, 01:29 ET Novartis Kymriah? receives FDA Regenerative Medicine Advanced Therapy designation in follicular lymphoma

Novartis today announced that the US Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to Kymriah? ...


Apr 21, 2020, 19:35 ET Seegene's Allplex? 2019-nCoV Assay receives FDA Emergency Use Authorization

Seegene, Inc. announced that U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for its Allplex? 2019-nCoV Assay, a...


Apr 21, 2020, 15:25 ET U.S. FDA Approves IMBRUVICA? (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL)

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of IMBRUVICA?...


Apr 21, 2020, 15:22 ET IMBRUVICA? (ibrutinib) Receives 11th FDA Approval

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved the ...


Apr 21, 2020, 02:00 ET Genome & Company re?oit l'autorisation DNR de la FDA pour le GEN-001, son premier microbiome thérapeutique anti-cancer

Genome & Company (KONEX : 314130), une société de biotechnologie qui développe des produits thérapeutiques innovants en immuno-oncologie, a annoncé...


Apr 21, 2020, 02:00 ET Genome & Company recibe el permiso IND de la FDA para GEN-001

Genome & Company (KONEX: 314130), una compa?ía de biotecnología que desarrolla productos terapéuticos innovadores en inmuno-oncología, anunció hoy...


Apr 21, 2020, 02:00 ET Genome & Company erh?lt IND-Genehmigung für GEN-001, sein erstes Mikrobiom-Therapeutikum gegen Krebs

Genome & Company (KONEX: 314130), ein Biotech-Unternehmen, das innovative Therapeutika im Bereich der Immun-Onkologie entwickelt, gab heute bekannt,...


Apr 20, 2020, 11:00 ET Transcenta Received IND Clearance from FDA for Initiating Clinical Trials for its Novel Humanized Claudin 18.2 Monoclonal Antibody TST001

Transcenta Holding Limited. ("Transcenta"), a global biotherapeutics company that fully integrates antibody-based biotherapeutics discovery, R&D and...


Apr 20, 2020, 08:30 ET ELITechGroup MDx LLC and OSANG Healthcare Join Fight Against COVID-19 in the United States Providing FDA Emergency Use Authorization Rapid Detection Test Kits

ELITechGroup MDx LLC, a leading global provider of diagnostic testing products, and its Korean partner, OSANG Healthcare, announced today that the...


Apr 20, 2020, 06:58 ET Development Update: U.S. FDA Grants Breakthrough Designation to CytoSorb for Removal of Ticagrelor During Cardiopulmonary Bypass in Emergent and Urgent Cardiothoracic Surgery

CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb? blood purification technology to treat...


Apr 20, 2020, 02:34 ET Genome & Company receives FDA IND clearance for GEN-001, its first anti-cancer microbiome therapeutic

Genome & Company (KONEX: 314130), a biotechnology company developing innovative therapeutics in immune-oncology, announced today that the United...


Apr 19, 2020, 20:00 ET Innovent Biologics Announces FDA Approval of Pemazyre? (Pemigatinib) as First Targeted Treatment for Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma

Innovent Biologics, Inc. ("Innovent" or "the Company") (HKEX: 1801), a world-class biopharmaceutical company that develops, manufactures and...


Apr 17, 2020, 14:07 ET FDA Approves First New Drug Under International Collaboration, A Treatment Option for Patients with HER2-Positive Metastatic Breast Cancer

Today, as part of Project Orbis, the U.S. Food and Drug Administration approved Tukysa (tucatinib) in combination with chemotherapy (trastuzumab and...


Apr 16, 2020, 17:30 ET Vent Multiplexor Receives FDA Emergency Use Authorization for Crisis Care Co-Ventilation During COVID-19 Pandemic

Vent Multiplexor, LLC (www.ventmultiplexor.com) and Yale New Haven Hospital announced today that the Food and Drug Administration has granted...


Apr 16, 2020, 17:00 ET CirrusDx Laboratory Receives Emergency Use Authorization from FDA for COVID-19 Testing

Cirrus Dx, Inc. (CirrusDx), an infectious disease laboratory and diagnostics company, received Emergency Use Authorization (EUA) from the US Food &...


Apr 16, 2020, 15:20 ET TissueTech Receives Regenerative Medicine Advanced Therapy (RMAT) Designation from U.S. Food and Drug Administration

TissueTech, Inc., the pioneer in the development and clinical application of regenerative human birth tissue products, announced today that the U.S....


Apr 16, 2020, 10:00 ET Clēan Works approved by Health Canada to sanitize N95 masks

BEAMSVILLE, ON, April 16, 2020 /PRNewswire/ - Clēan Works is pleased to announce that it has been approved by Health Canada to join the fight against ...


Apr 16, 2020, 08:45 ET ThermoGenesis Receives Acknowledgement Letter from FDA Allowing Its SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit for Distribution

ThermoGenesis Holdings, Inc. (Nasdaq: THMO), a market leader in automated cell processing tools and services in the cell and gene therapy field,...


Apr 16, 2020, 00:30 ET Mayne Pharma Submits New Drug Application for E4/DRSP to the FDA

Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) today announced that Mayne Pharma has submitted a New ...