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.

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Jul 06, 2020, 22:26 ET U.S. FDA Approves Qwo™ (collagenase clostridium histolyticum-aaes), the First Injectable Treatment for Cellulite

Endo International plc (NASDAQ: ENDP) today announced that it received U.S. Food and Drug Administration (FDA) approval of Qwo™ (collagenase...


Jul 02, 2020, 05:00 ET HeiQ Viroblock Certified as Cosmetic Grade and Bio-based Renewable

Textile innovator HeiQ's antiviral textile technology, HeiQ Viroblock NPJ03, has been certified as safe and sustainable as all its ingredients are...


Jun 16, 2020, 07:00 ET Valeo Pharma Receives FDA Approval for Ethacrynate Sodium

U.S. Ethacrynate Sodium to be launched summer 2020 First U.S. regulatory approval received by Valeo Pharma Valeo to pursue Ethacrynate Sodium...


Jun 09, 2020, 07:11 ET Charlotte's Web Steps up to Support Research to Address FDA's Request for More Scientific Data

ValidCare to Conduct Industry Leading Study on CBD and Human Health BOULDER, Colo., June 9, 2020 /CNW/ - (TSX: CWEB) (OTCQX: CWBHF) Charlotte's Web...


Jun 02, 2020, 06:00 ET Cellenkos® Inc. Announces FDA Clearance to Initiate Phase 1 Double- Blinded, Randomized, Placebo-Controlled Trial of Cryopreserved Cord Blood-Derived T-Regulatory Cells (CK0802) for Treatment of COVID-19 Associated Acute Respiratory Distress Syndrome

Cellenkos Inc., a privately held, clinical stage biotech company announced today that the US Food & Drug Administration (FDA) has cleared the way to...


Jun 01, 2020, 06:30 ET HLS Therapeutics to Become Distributor of the Saladax MyCare™ Psychiatry Line including the Insite Point-of-Care Device and Antipsychotic Reagents

The MyCare Insite is a point-of-care (POC) device that uses just a single drop of blood to measure the most commonly used antipsychotic drugs in...


May 26, 2020, 07:00 ET SMART Medical Systems Receives FDA Clearance for Its G-EYE® Colonoscope

SMART Medical Systems Ltd., a developer and manufacturer of innovative endoscopy products, announced that the FDA issued 510(k) clearance for its...


May 19, 2020, 06:00 ET Invivoscribe Announces FDA Approval for Distribution of the LeukoStrat CDx FLT3 Mutation Assay as an IVD Kit in the United States

Invivoscribe to offer the LeukoStrat® CDx FLT3 Mutation Assay as an FDA approved kit with analysis software. In 2017, Invivoscribe's LeukoStrat® CDx...


May 13, 2020, 12:54 ET Hetero Enters Into a Licensing Agreement With Gilead Sciences, Inc. for the Manufacturing and Distribution of "Remdesivir" in 127 Countries, Including India, for COVID-19

Hetero, one of India's leading generic pharmaceutical companies and the world's largest producer of anti-retroviral drugs, announced today that it...


May 13, 2020, 06:24 ET Fluxergy Announces $30 Million to Expand Manufacturing Capacity of Its One-hour Point-of-care Diagnostic Testing System in Response to COVID-19

Irvine, California-based Fluxergy LLC, a diagnostic test company, is making a $30 million investment to expand its capability to scale production of...


May 04, 2020, 10:06 ET New Corona Antibody Test Made in Germany "99.8% Accurate"

Roche launched the new serological (antibody-based) test at the company's Penzberg laboratory on Monday, May 4 at a press conference attended by...


Apr 29, 2020, 07:00 ET FDA Approves Ortho Dermatologics' Labeling For JUBLIA® (efinaconazole) Topical Solution, 10%, In Patients As Young As Six Years Old

Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health...


Apr 27, 2020, 04:22 ET Green Valley Obtains IND Approval from U.S. FDA for Sodium Oligomannate's International, Phase III Clinical Study

On April 8, 2020, Shanghai Green Valley Pharmaceuticals, China received the formal decision letter from the US Food and Drug Administration (FDA) on...


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

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


Apr 15, 2020, 07:07 ET U.S. FDA Issues GRAS No Objection Letter for Inulin from Jerusalem Artichoke

On November 08, 2019 – The U.S. Food and Drug Administration (FDA) issued a GRAS (Generally Recognized As Safe) No Objection Letter, for Intrinsic...


Apr 07, 2020, 08:32 ET Sectra and Hospital for Special Surgery Collaborate to Integrate FDA Approved Digital Pathology Imaging Solution

International medical imaging IT and cybersecurity company Sectra (STO: SECT B) has gone live with an initial phase of its digital pathology solution ...


Apr 01, 2020, 08:01 ET FDA Clearance--Sectra's Digital Pathology Solution Available for Primary Diagnostics and Remote Reading in the U.S.

International medical imaging IT and cybersecurity company Sectra (STO: SECT B) has received a 510(k) clearance by the US Food & Drug Administration...


Mar 11, 2020, 12:00 ET FDA Clears Fluidda's Broncholab Platform for Use in Clinical Practice

The US Food and Drug Administration provided market clearance to Fluidda for its Broncholab platform. Broncholab provides a number of Functional...


Mar 05, 2020, 10:00 ET Purolite® Protein A Chromatography Resin Implemented Into FDA-approved Commercial Manufacturing of Monoclonal Antibody Treatments

Purolite Ltd., a leading manufacturer of resin-based separation, purification and extraction technologies, today announces that Praesto® Jetted A50,...


Jan 15, 2020, 13:00 ET CIMZIA® (certolizumab pegol) Now Approved in Canada for the Treatment of Non-Radiographic Axial Spondyloarthritis

OAKVILLE, ON, Jan. 15, 2020 /CNW/ - UCB Canada Inc. announced today that Health Canada has approved CIMZIA® (certolizumab pegol) for the treatment of ...


Jan 14, 2020, 07:07 ET Health Canada Approves Astellas' XOSPATA® (gilteritinib) for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation

XOSPATA is the first and only targeted treatment approved by Health Canada for patients with relapsed or refractory Acute Myeloid Leukemia with a...


Jan 13, 2020, 09:00 ET Opsens Receives FDA Approval of Optowire III

IMPROVED HANDLING AND LOWER COST OF PRODUCTION QUEBEC CITY, Jan. 13, 2020 /CNW Telbec/ - Opsens Inc. ("Opsens" or the "Company") (TSX: OPS) (OTCQX:...


Jan 13, 2020, 06:45 ET Ortho Dermatologics Announces Publication Of Pivotal Phase 3 Data On ARAZLO™ (tazarotene) Lotion, 0.045% In The Journal Of Drugs In Dermatology (JDD)

Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health...


Jan 09, 2020, 07:30 ET CPDC's Radiopharmaceutical Manufacturing Facility Receives Clearance from FDA

HAMILTON, ON, Jan. 9, 2020 /CNW/ - The Centre for Probe Development and Commercialization (CPDC), a global leader in the development, production and...