FDA Approvals
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BioNTech inked an exclusive worldwide license and collaboration agreement with OncoC4 to develop and commercialize its investigational anti-CTLA-4 antibody ONC-392 for solid tumors.
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Brainomix Receives FDA Clearance for Its Flagship Stroke AI Imaging Software
3/21/2023
Brainomix today announced that its Brainomix 360 e-ASPECTS tool for stroke has received FDA clearance, enabling the Oxford-based company to deploy its cutting-edge stroke AI imaging platform to US stroke centers.
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ICHNOS SCIENCES RECEIVES ORPHAN DRUG DESIGNATION FOR FIRST-IN-CLASS BISPECIFIC (CD38 x CD47) ANTIBODY INNATE CELL MODULATOR, ISB 1442
3/21/2023
Ichnos Sciences Inc. today announced the company has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for its first-in-class biparatopic 2+1 BEAT® bispecific antibody targeting CD38 and CD47 for the treatment of relapsed/refractory multiple myeloma (MM).
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Viz.ai is First to Receive FDA 510(k) Clearance for AI Algorithm for Abdominal Aortic Aneurysm
3/21/2023
Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its algorithm intended to detect suspected abdominal aortic aneurysm (AAA).
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Intellia Therapeutics Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to NTLA-2002 for the Treatment of Hereditary Angioedema
3/21/2023
Intellia Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to NTLA-2002 for the treatment of hereditary angioedema (HAE).
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Biomarkers as a surrogate endpoint in ALS will go on trial on March 22 as Biogen and Ionis’s tofersen faces the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee.
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Techdow USA Announces FDA Approval of Generic Lovenox®, (Enoxaparin Sodium – Preservative Free) In Prefilled Syringes
3/20/2023
Techdow USA Inc. (“Techdow USA”), a growing market leader and vertically integrated generic injectables company, today announced the FDA approval of Enoxaparin Sodium (Preservative Free) in Prefilled Syringes for the U.S. market.
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FORE Biotherapeutics Receives FDA Orphan Drug Designation for FORE8394 for the Treatment of Primary Brain and CNS Malignancies
3/20/2023
FORE Biotherapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead program, FORE8394, for the treatment of primary brain and central nervous system (CNS) malignancies.
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Arrowhead Receives FDA Fast Track Designation for ARO-APOC3
3/20/2023
Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ARO-APOC3 for reducing triglycerides in adult patients with familial chylomicronemia syndrome (FCS).
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NuVasive Specialized Orthopedics Expands Indications of Precice Limb Lengthening System to Treat Pediatric Patients
3/20/2023
NuVasive, Inc. today announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the use of its Precice all-internal limb lengthening solution to include pediatric patients*.
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Asensus Surgical Receives FDA 510(k) Clearance For Pediatric Indication for Senhance Surgical System Senhance Offers the First and Only Digital Laparoscopic Surgery Solution for Pediatric Patients
3/20/2023
Asensus Surgical, Inc. today announced that it has received 510(k) clearance from the FDA for an expanded indication to treat pediatric patients with the Senhance® System.
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FDA Approves Expanded Indication for Telix's Illuccix® to Include Patient Selection for PSMA-Directed Radioligand Therapy
3/16/2023
Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States Food and Drug Administration (FDA) has approved a supplementary New Drug Application (sNDA) for Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection) to enable its use for the selection of patients with metastatic prostate cancer, for whom 177Lu 177 PSMA-directed therapy is indicated.
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Novartis Tafinlar + Mekinist approved by FDA for pediatric patients with BRAF V600E low-grade glioma, the most common pediatric brain cancer
3/16/2023
Novartis announced the U.S. Food and Drug Administration granted approval for Tafinlar® + Mekinist® for the treatment of pediatric patients 1 year of age and older with low-grade glioma with a BRAF V600E mutation who require systemic therapy.
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BD Receives FDA 510(k) Clearance for First-of-Its-Kind High-Throughput Diagnostic Test for Infectious Vaginitis
3/16/2023
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the BD Vaginal Panel on the BD COR™ System.
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Weeks after the FDA rejected Veru’s Emergency Use Authorization bid for sabizabulin in COVID-19, the company announced plans to continue with late-stage development of the drug.
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Cognition Therapeutics Announces Development Plans for Oral CT1812 in Geographic Atrophy Secondary to Dry AMD
3/15/2023
Cognition Therapeutics, Inc. (NASDAQ: CGTX) announced that its Investigational New Drug (IND) application for the investigation of CT1812 for geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD) has been cleared by the U.S. Food and Drug Administration (FDA).
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Sapience Therapeutics Receives IND Clearance from FDA to Proceed with Phase 1-2 Study of ST316 in Patients with Solid Tumors
3/14/2023
Sapience Therapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) cleared the Company to proceed with its Phase 1-2 clinical trial of ST316 for the treatment of solid tumors.
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The FDA has one target action date and one advisory committee meeting scheduled for this week. It is also gearing up for an adcomm that could prove to be pivotal for neurodegenerative diseases.
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Vivasure Medical Announces FDA IDE Approval to Initiate U.S. Pivotal Study
3/13/2023
Vivasure Medical ® Limited today announced that the U.S. Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to advance the company’s PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and effectiveness of the Vivasure PerQseal® Closure Device System.
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The FDA has approved Pfizer’s nasal spray, zavegepant, now to be marketed as Zavzpret, for the acute treatment of migraine in adults, the company announced Friday.