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

Aug 21, 2020, 07:06 ET LumiraDx reçoit l'autorisation d'utilisation d'urgence de la FDA pour le test de l'antigène de la COVID-19 au point d'intervention

LumiraDx, la société de diagnostic au point d'intervention de nouvelle génération, a annoncé aujourd'hui avoir reçu l'autorisation d'utilisation...


Aug 21, 2020, 06:53 ET LumiraDx erhält EUA von der FDA für Point-of-Care-COVID-19-Antigentest

LumiraDx, das Unternehmen für Point-of-Care-Diagnostik der nächsten Generation, gab heute bekannt, dass es von der US-amerikanischen Food and Drug...


Aug 20, 2020, 18:43 ET U.S. FDA Approves New DARZALEX® (daratumumab)-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma

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


Aug 20, 2020, 17:33 ET FDA Approves New KYPROLIS® (carfilzomib) Combination Regimen With DARZALEX® (daratumumab) And Dexamethasone In Both Once- And Twice-Weekly Dosing Regimens

Amgen (NASDAQ:AMGN) today announced the U.S. Food and Drug Administration (FDA) has approved the expansion of the KYPROLIS® (carfilzomib) U.S....


Aug 20, 2020, 14:29 ET FDA approves Novartis Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis

Novartis today announced that the US Food and Drug Administration (FDA) has approved Kesimpta® (ofatumumab, formerly OMB157) as an injection for...


Aug 20, 2020, 14:24 ET LumiraDx recibe la autorización para uso de emergencia de la FDA para su test de antígenos de COVID-19 en punto de atención

LumiraDx, la compañía de diagnósticos en el punto de atención de próxima generación, anunció hoy que ha recibido una Autorización de Uso de...


Aug 20, 2020, 14:08 ET COVID-19: La FDA aprueba el uso del test LumiraDx en el punto de atención

LumiraDx, la compañía de diagnóstico en el punto de atención de próxima generación, ha anunciado hoy que ha recibido la autorización de uso de...


Aug 20, 2020, 10:59 ET LumiraDx recebe autorização de uso de emergência da FDA para teste de antígeno para a COVID-19 em ponto de cuidado

A LumiraDx, a empresa de diagnóstico em ponto de cuidado da próxima geração, anunciou hoje que recebeu autorização de uso de emergência (AUE) da...


Aug 20, 2020, 10:25 ET Romark Announces FDA Approval Of New Manufacturing Facility In Manati, Puerto Rico

Romark, a research-based pharmaceutical company focused on the discovery, development and delivery of innovative new medicines, primarily in the...


Aug 20, 2020, 08:03 ET U.S. FDA grants rare pediatric disease 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) Offices of Pediatric...


Aug 20, 2020, 06:00 ET LumiraDx Receives FDA Emergency Use Authorization for Point of Care COVID-19 Antigen Test

LumiraDx, the next-generation point of care diagnostic company, announced today that it has received Emergency Use Authorization (EUA) from the U.S....


Aug 20, 2020, 00:00 ET Polaryx Therapeutics Receives FDA Fast Track Designation to PLX-200 for the Treatment of Patients With Juvenile Neuronal Ceroid Lipofuscinosis

Polaryx Therapeutics Inc., a biotech company developing small molecule therapeutics for lysosomal storage disorders, announced today that the U.S....


Aug 19, 2020, 13:04 ET Softwave® Tissue Regeneration Technologies Announces Landmark Trial for Acute Traumatic Spinal Cord Injuries

SoftWave® Tissue Regeneration Technologies, a disruptive bio-medical device company, announces the beginning of a trial for "Extracorporeal Shock...


Aug 19, 2020, 08:00 ET BioMarin Receives Complete Response Letter (CRL) from FDA for Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A

BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL)...


Aug 19, 2020, 07:00 ET Mylan Brings Critical Access to the Multiple Sclerosis Community by Launching a More Affordable Treatment Option Through a First Generic to Tecfidera®

Mylan N.V. (NASDAQ: MYL) today announced the launch of the first FDA-approved therapeutically equivalent, substitutable generic of Biogen's...


Aug 18, 2020, 09:43 ET IlluminOss Medical Receives FDA Clearance for Use in Fibula Fractures

IlluminOss Medical, a medical device company focused on minimally invasive orthopedic fracture repair, today announced that it has received expanded...


Aug 18, 2020, 07:30 ET ClearMask receives FDA clearance for world's first fully transparent surgical mask

ClearMask LLC, a privately held American medical supply company, announced today that it received the U.S. Food and Drug Administration's 510(k)...


Aug 17, 2020, 13:40 ET FDA Approves Treatment for Rare Disease Affecting Optic Nerves, Spinal Cord

The U.S. Food and Drug Administration has approved Enspryng (satralizumab-mwge) for the treatment of neuromyelitis optica spectrum disorder (NMOSD)...


Aug 13, 2020, 09:24 ET SWORD Health Becomes The Only Digital Musculoskeletal Care Provider With HITRUST®, SOC 2 And FDA Certifications

SWORD Health, a leading provider of digital musculoskeletal (MSK) care, today announced SWORD Health's digital therapy platform and several of its...


Aug 13, 2020, 08:00 ET InMode Introduces the Morpheus8 Platform and the Morpheus8 Body Fractional Technology

InMode Ltd. (Nasdaq: INMD) ("InMode"), a leading global provider of innovative medical technologies, is pleased to announce a new FDA clearance to...


Aug 12, 2020, 15:55 ET NS Pharma's VILTEPSO™ (viltolarsen) injection Now FDA-Approved in the U.S. for the Treatment of Duchenne Muscular Dystrophy in Patients Amenable to Exon 53 Skipping Therapy

NS Pharma, Inc. (NS Pharma; President, Tsugio Tanaka), a wholly owned subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku; President Shigenobu...


Aug 12, 2020, 14:16 ET FDA Approves Targeted Treatment for Rare Duchenne Muscular Dystrophy Mutation

Today, the U.S. Food and Drug Administration granted accelerated approval to Viltepso (viltolarsen) injection for the treatment of Duchenne muscular...


Aug 12, 2020, 03:00 ET KAHR Medical Announces FDA Clearance of IND Application for DSP107, anti-CD47 Candidate for the Treatment of Solid Tumors

KAHR Medical, a cancer immunotherapy company developing novel bi-functional fusion proteins, announced today that the U.S. Food and Drug...


Aug 11, 2020, 16:15 ET Cardiff Oncology Announces Second Quarter 2020 Results and Highlights

Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical...


Aug 11, 2020, 08:00 ET MagVenture recebe autorização do FDA para TOC

O FDA liberou a terapia de TMS/EMT da MagVenture® para complementar tratamento de Transtorno obsessivo-compulsivo (TOC). Esta é a segunda indicação...