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

Nov 18, 2020, 17:44 ET Actualización sobre el coronavirus (COVID-19): La FDA autoriza la primera prueba de COVID-19 para autodiagnosticarse en el hogar

Hoy, la Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) emitió una autorización de uso de emergencia (EUA)...


Nov 18, 2020, 12:00 ET Invent Medical Corporation Receives EUA approval for HFT 150™ Heated High Flow System

Invent Medical Corporation is pleased to announce the EUA approval on their HFT 150™ heated high flow system. Sam Chang, CEO comments, "After four...


Nov 18, 2020, 08:00 ET PTC Therapeutics Announces Key Regulatory Designations for PTC596 to Advance Treatment of Two Rare Oncology Indications

PTC Therapeutics, Inc. (NASDAQ: PTCT), today announced that the United States (U.S.) Food and Drug Administration (FDA) has granted PTC596 both...


Nov 18, 2020, 07:10 ET QBiotics' STELFONTA® Receives FDA Approval for Canine Mast cell Tumours

QBiotics Group Limited (QBiotics), a life sciences company developing novel anticancer and wound healing pharmaceuticals, is delighted to announce...


Nov 17, 2020, 22:30 ET Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at...


Nov 17, 2020, 09:04 ET Allotrope Medical Announces FDA Clearance of StimSite™

Allotrope Medical™ Inc., a company committed to advancing surgical safety and precision, today announced its FDA clearance of their device, StimSite. ...


Nov 17, 2020, 09:00 ET Sysmex America to Distribute FDA Cleared CellaVision® DC-1 for Low-Volume Hematology Labs

Sysmex America, Inc., a leading diagnostic company offering hematology, urinalysis, informatics systems and flow cytometry testing solutions for...


Nov 17, 2020, 09:00 ET ELITechGroup MDx LLC Announces FDA Emergency Use Authorization Submission for SARS-CoV-2 Plus ELITe MGB® Assay

Today, ELITechGroup MDx LLC, a leading global provider of molecular diagnostic testing products, announced it submitted the SARS-CoV-2 Plus ELITe...


Nov 17, 2020, 07:00 ET Alkermes Receives FDA Complete Response Letter Related to ALKS 3831 Manufacturing Records Review

Alkermes plc (Nasdaq: ALKS) today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA)...


Nov 17, 2020, 07:00 ET UCB's VIMPAT® (lacosamide) CV now approved by FDA for primary generalized tonic-clonic seizures and expanded pediatric use for people living with epilepsy

UCB, a global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved VIMPAT® (lacosamide) CV as...


Nov 17, 2020, 07:00 ET RedHill Biopharma's Second COVID-19 Candidate, RHB-107, Cleared by FDA for Phase 2/3 Study in Symptomatic COVID-19 Disease

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the U.S. Food and...


Nov 17, 2020, 05:07 ET SafKan Health Announces FDA 510(k) Clearance for First-of-its-Kind OtoSet™ Ear Cleaning System

Genesis Innovation Group's cultivate(MD) Capital Fund II LP, a fund focused on investments into early stage healthcare companies with innovative...


Nov 16, 2020, 13:59 ET FDA Approves First Intratumoral Injection to Treat Non-Metastatic Mast Cell Tumors in Dogs

Today, the U.S. Food and Drug Administration approved Stelfonta (tigilanol tiglate injection) to treat dogs with non-metastatic, skin-based...


Nov 16, 2020, 07:45 ET Windtree Therapeutics Reports Third Quarter 2020 Financial Results and Provides Key Business Updates

Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology and medical device company focused on advancing multiple late-stage interventions for...


Nov 16, 2020, 07:00 ET INOVIO Announces Initiation of Phase 2 Segment of its Phase 2/3 Clinical Trial for its COVID-19 DNA Vaccine Candidate, INO-4800; Trial Will Be Funded by the U.S. Department of Defense

INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from...


Nov 13, 2020, 16:27 ET Breckenridge Announces Final Approval of its ANDA for Pomalidomide Capsules (generic for Pomalyst®)

Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has approved Breckenridge's Abbreviated New Drug...


Nov 12, 2020, 10:00 ET New FDA Cleared Automated Ear Cleaning Device Brings Ear Care Into the 21st Century

SafKan Health, a medical device company that has developed the first automated ear cleaning device for the 35 million Americans affected by impacted...


Nov 10, 2020, 17:05 ET Sebela Pharmaceuticals Receives FDA Approval for SUTAB® Tablets for Colonoscopy Preparation

Sebela Pharmaceuticals® today announces that the U.S. Food and Drug Administration (FDA) approved SUTAB® (sodium sulfate, magnesium sulfate, and...


Nov 10, 2020, 07:43 ET icotec ag Receives FDA Clearance for the VADER® Pedicle - System with Bone Cement Augmentation

icotec ag, the leading medical device manufacture of Carbon/PEEK spinal implants, announces the U.S. Food and Drug Administration (FDA) 510(k)...


Nov 09, 2020, 09:25 ET Cannabics Concludes a Pre-Clinical Study on Human Biopsies in Preparation for FDA pre-IND Meeting Request on Colorectal Cancer Drug Candidate RCC-33

Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based therapeutic formulations and...


Nov 09, 2020, 08:33 ET NuVasive's Thoracolumbar Interbody Portfolio Receives First Clearance in the US for the Treatment of Sagittal Deformities

NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive,...


Nov 09, 2020, 07:30 ET GenScript Receives FDA Emergency Use Authorization for World's First SARS-CoV-2 Neutralizing Antibody Detection Kit

GenScript USA Inc., the world's leading research reagent provider, announced today that the U.S. Food and Drug Administration (FDA) has granted...


Nov 08, 2020, 19:01 ET Liminal BioSciences Announces FDA Extension of Review Period for Ryplazim®(plasminogen) BLA

PDUFA date extended by FDA from March 5, 2021 to June 5, 2021 Earnings call moved forward to Wednesday November 11th LAVAL, QC, and CAMBRIDGE,...


Nov 06, 2020, 18:21 ET Actualización sobre el coronavirus: La FDA autoriza la primera prueba que detecta anticuerpos neutralizantes de una infección reciente o anterior de SARS-CoV-2

Hoy, la Administración de Alimentos y Medicamentos de los EE. UU (FDA, por sus siglas en inglés) autorizó la primera prueba de serología que detecta...


Nov 05, 2020, 10:02 ET Quansys Biosciences Receives FDA Emergency Use Authorization for its SARS-CoV-2 IgG Antibody Test that Provides Exceptional Clinical Performance

Quansys Biosciences announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its...