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 23, 2020, 15:34 ET Viatris Inc. Announces FDA Tentative Approval of a Pediatric Formulation of Dolutegravir (DTG) Under PEPFAR

Viatris Inc. (NASDAQ: VTRS), a new kind of healthcare company, today announced tentative approval from the U.S. Food and Drug Administration (FDA)...


Nov 23, 2020, 12:41 ET FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention

Today, the U.S. Food and Drug Administration expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of ...


Nov 23, 2020, 09:00 ET FDA Clears First of its Kind Algorithm Suite for Personal ECG

AliveCor, the leader in AI-based personal ECG technology and provider of enterprise cardiology solutions, today announced that the US FDA had given...


Nov 21, 2020, 20:17 ET Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together...


Nov 20, 2020, 18:02 ET First-Ever Treatment for Rare Rapid-Aging Disease Progeria Receives U.S. FDA Approval

The Progeria Research Foundation (PRF) today announced a historic milestone with the U.S. Food and Drug Administration (FDA) approval of Zokinvy™...


Nov 20, 2020, 17:53 ET Eiger BioPharmaceuticals Announces FDA Approval of Zokinvy™ (lonafarnib): The First Treatment for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies

Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare...


Nov 20, 2020, 17:47 ET FDA Approves First Treatment for Hutchinson-Gilford Progeria Syndrome and Some Progeroid Laminopathies

Today, the U.S. Food and Drug Administration approved Zokinvy (lonafarnib) capsules to reduce the risk of death due to Hutchinson-Gilford progeria...


Nov 20, 2020, 12:40 ET FDA grants Emergency Use Authorisation for baricitinib in hospitalised COVID-19 patients nine months after initial hypothesis was published by BenevolentAI

BenevolentAI, announced today that baricitinib, a drug it first identified as a potential treatment for COVID-19 by the company has been granted...


Nov 20, 2020, 07:30 ET THINK Surgical® Receives FDA Clearance of Second-Generation Active Robot

THINK Surgical, an innovator in the field of orthopedic active robot surgery, announced today that the Food and Drug Administration (FDA) has cleared ...


Nov 19, 2020, 17:20 ET Baricitinib Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized Patients with COVID-19

Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) issued an Emergency Use...


Nov 19, 2020, 08:45 ET Seelos Therapeutics Receives US Orphan Drug Designation for SLS-005 (Trehalose) in Amyotrophic Lateral Sclerosis

Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous...


Nov 19, 2020, 07:30 ET Armis Biopharma Announces FDA 510(k) Clearance for VeriFixx™ Small Bone Implant

Armis Biopharma, Inc. announced today the U.S. Food and Drug Administration (FDA) has provided 510(k) clearance for the VeriFixx™ Small Bone Implant...


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 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, 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, 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...