Food and Drug Administration (FDA)

25326 articles with Food and Drug Administration (FDA)

• Incyte Provides Regulatory Update on Ruxolitinib Extended-Release Tablets

  3/24/2023

  Incyte announced that the U.S. Food and Drug Administration has issued a complete response letter for ruxolitinib extended-release tablets, a JAK1/JAK2 inhibitor, for once-daily use in the treatment of certain types of myelofibrosis, polycythemia vera and graft-versus-host disease.

• FDA Takes Additional Steps to Improve Nutrition, Reduce Disease with Expanded Use of Salt Substitutes to Help Lower Sodium Intake

  3/24/2023

  Today, the U.S. Food and Drug Administration proposed changes to the standards of identity (SOIs) for foods that include salt to permit the use of safe and suitable salt substitutes.

• ONO PHARMA USA's Tirabrutinib Receives Orphan Drug Designation from the FDA for the Treatment of Primary Central Nervous System Lymphoma

  3/23/2023

  ONO PHARMA USA, INC., announced that its candidate, tirabrutinib, a Bruton's tyrosine kinase inhibitor, was granted Orphan Drug Designation on March 21, 2023 by the U.S. Food and Drug Administration for the treatment of patients with primary central nervous system lymphoma.

• Ionis announces FDA advisory committee voted unanimously for a potential accelerated approval of tofersen for SOD1-ALS

  3/23/2023

  Ionis announced the outcome of the U.S. Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee meeting on tofersen, an investigational antisense medicine for the treatment of people with superoxide dismutase 1 amyotrophic lateral sclerosis.

• Creative Medical Technology Files Orphan Drug Designation Application with the U.S. FDA Using the ImmCelz® Platform for the Treatment of Brittle Type 1 Diabetes

  3/23/2023

  Creative Medical Technology Holdings, Inc. announced that it filed an application with the U.S. Food and Drug Administration to receive Orphan Drug Designation for the treatment of Brittle Type 1 Diabetes using its ImmCelz® platform.

• TELA Bio Announces 510(k) Clearance for OviTex® PRS Long-Term Resorbable for Plastic and Reconstructive Surgery

  3/23/2023

  TELA Bio, Inc today announced that the U.S. Food and Drug Administration has granted 510(k) clearance for the Company's OviTex PRS Long-Term Resorbable product.

• Dyne Therapeutics Receives FDA Orphan Drug and Rare Pediatric Designations for DYNE-251 for the Treatment of Duchenne Muscular Dystrophy

  3/23/2023

  Dyne Therapeutics, Inc. today announced that DYNE-251 was granted U.S. Food and Drug Administration (FDA) orphan drug and rare pediatric disease designations.

• Biogen Provides Update on FDA Advisory Committee Meeting on Tofersen for SOD1-ALSSOD1-ALS is a rare genetic form of the disease affecting approximately 330 people in the United States

  3/23/2023

  Biogen Inc. announced the outcome of the U.S. Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee meeting on tofersen, an investigational product for the treatment of superoxide dismutase 1 amyotrophic lateral sclerosis.

• FDA Approves First-in-class Evkeeza® (evinacumab-dgnb) for Young Children with Ultra-rare Form of High Cholesterol

  3/22/2023

  Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has extended the approval of Evkeeza® (evinacumab-dgnb) as an adjunct to other lipid-lowering therapies to treat children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH).

• Avadel Pharmaceuticals Announces FDA Authorization to Import Tentatively-Approved LUMRYZ™ Ahead of Anticipated Final Approval Decision

  3/22/2023

  Avadel Pharmaceuticals plc today announced that the U.S. Food and Drug Administration (“FDA”) has approved its Pre-Launch Activities Importation Requests (PLAIR) for LUMRYZ.

• FDA Roundup: March 21, 2023

  3/21/2023

  The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

• 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).

• 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).

• Prestige Biopharma Receives FDA Fast Track Designation for PBP1510 in the Treatment of Pancreatic Cancer

  3/21/2023

  Prestige Biopharma has received Fast Track designation from the U.S. Food and Drug Administration for PBP1510, in the treatment of unresectable or metastatic pancreatic adenocarcinoma that has relapsed following and/or is refractory to at least one line of prior therapy.

• 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.

• 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).

• Karuna Therapeutics Announces Positive Results from Phase 3 EMERGENT-3 Trial of KarXT in Schizophrenia

  3/20/2023

  Karuna Therapeutics, Inc. announced positive topline results from its Phase 3 EMERGENT-3 trial evaluating the efficacy, safety, and tolerability of its lead investigational therapy, KarXT in adults with schizophrenia.

• 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.

• 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*.

• Milla Pharmaceuticals Inc. and the Alter Pharma Group Announce Launch of a Generic Version of Magnesium Sulfate in Water for Injection, in Non-PVC, Single-Patient Use Containers by Their Partner Athenex Pharmaceutical Division (APD)

  3/20/2023

  Milla Pharmaceuticals Inc., a subsidiary of the Alter Pharma Group, announced that its partner, Athenex Pharmaceutical Division, has just started to commercialize its abbreviated new drug application approval from the U.S. Food and Drug Administration for its Generic Version of Magnesium Sulfate in Water for Injection, 2 g/50 mL, 4 g/100 mL and 4 g/50 mL, in Non-PVC, Single-Patient Use Containers.