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VERTEX PHARMACEUTICALS: Vertex Submits New Drug Application to the U.S. FDA for Triple Combination Regimen of VX-445 (Elexacaftor), Tezacaftor and Ivacaftor in Cystic Fibrosis

By Press release submission | Jul 22, 2019

PARAGON BIOSCIENCES: Launches Qlarity Imaging to Advance the First FDA-Cleared Artificial Intelligence Breast Cancer Diagnosis System

By Press release submission | Jul 19, 2019

FDA approves fast-tracking of Parkinson’s treatment

By Hollie Ferguson | Jul 17, 2019

Latest News

MERCK: FDA Approves Merck’s RECARBRIO™ (imipenem, cilastatin, and relebactam) For the Treatment of Adults with Complicated Urinary Tract and Complicated Intra-Abdominal Bacterial Infections Where Limited or No Alternative Treatment Options Are Available

By Press release submission | Jul 17, 2019

Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved RECARBRIO™ (imipenem, cilastatin, and relebactam) for injection, 1.25 grams, a new combination antibacterial. RECARBRIO is indicated in patients 18 years of age and older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, and Pseudomonas aeruginosa.

ERCHONIA: FDA Clears Erchonia's FX 635 for Relief of Chronic Musculoskeletal Pain

By Press release submission | Jul 17, 2019

Erchonia Corporation, the global leader in the manufacturing and development of low level laser therapy technology ("3LT"), announces that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its FX 635 low level laser for the temporary relief of chronic, nociceptive musculoskeletal pain.

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new treatment for complicated urinary tract and complicated intra-abdominal infections

By Press release submission | Jul 17, 2019

The U.S. Food and Drug Administration has approved Recarbrio (imipenem, cilastatin and relebactam), an antibacterial drug product to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).

Treatment approved for rhinosinusitis with nasal polyps

By Keri Carbaugh | Jul 16, 2019

Dupixent, an injectable medication, was approved by the Food and Drug Administration for the treatment of chronic rhinosinusitis (prolonged inflammation of the sinuses and nasal cavity) with nasal polyps (growths on the inner lining of the sinuses).

Dravet Syndrome drug submitted for investigation

By Keri Carbaugh | Jul 16, 2019

An investigational new drug application and fast track designation request for EPX-100, a treatment for Dravet Syndrome, were submitted to the Food and Drug Administration.

TEVA PHARMACEUTICAL INDUSTRIES LTD: Teva Announces FDA Approval of AirDuo® Digihaler™ (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder

By Press release submission | Jul 15, 2019

The First Digital Maintenance Asthma Inhaler Therapy with Integrated Sensors Joins Teva’s Digital Rescue Inhaler Therapy to Provide Patients with Technology to Track Treatment Use

BAYER: FDA approves Bayer's Gadavist® (gadobutrol) injection as the first and only contrast agent for use in cardiac MR in adult patients with known or suspected coronary artery disease

By Press release submission | Jul 15, 2019

Coronary artery disease (CAD) is an important public health issue-- a disease that affects 16.5 million Americans

SENSORION: Receives FDA IND Approval for Arazasetron (SENS-401)

By Press release submission | Jul 13, 2019

Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN) a pioneering clinical-stage biopharmaceutical company which specializes in the development of novel therapies to restore, treat and prevent inner ear diseases such as hearing loss, tinnitus and vertigo, announces that it has received the Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to proceed with SENS-401, based on preclinical data and clinical development plan.

ABBOTT: Announces FDA Approval of the Alinity™ s System, the Latest Technology for Screening and Protecting the U.S. Blood and Plasma Supply

By Press release submission | Jul 13, 2019

Alinity™ s System will screen the U.S. blood and plasma supply faster and more efficiently while maintaining highest levels of accuracy

LA ROCHE-POSAY: Changes The Face Of Acne With Latest FDA Approved Acne Ingredient And Premieres Artificial Intelligence-Based Skin Analysis

By Press release submission | Jul 12, 2019

La Roche-Posay Launches Effaclar Adapalene Gel 0.1% Acne Treatment and My Skin Track PoreScan

AZURITY PHARMACEUTICALS: FDA Approves Katerzia™, the First and Only Amlodipine Oral Suspension, 1 mg/mL, for Pediatric Patients 6 Years of Age and Older

By Press release submission | Jul 10, 2019

Azurity Pharmaceuticals, a specialty pharmaceutical company that makes safe, high-quality treatments for patients requiring customized formulations for their care, announced today that the U.S. Food and Drug Administration (FDA) has approved Katerzia (amlodipine) Oral Suspension, 1 mg/mL, the first and only FDA-approved amlodipine oral suspension. Katerzia is indicated for the treatment of hypertension (high blood pressure) in adults and pediatric patients 6 years of age and older and coronary artery disease in adults.

CONTIPI MEDICAL LTD: Has Received FDA Approval for the Marketing of a Unique Product for the Treatment of Pelvic Organ Prolapse in Women

By Press release submission | Jul 10, 2019

This week, ConTIPI Medical Ltd. received US Food and Drug Administration (FDA) approval to market its new product, the first of its kind, designed to treat pelvic prolapse in women (such as the uterus and bladder).

Daiichi Sankyo issues update on new cancer drug

By Chris Adams | Jul 8, 2019

Japanese pharmaceutical company Daiichi Sankyo recently announced it received a complete response letter (CRL) from the Food and Drug Administration (FDA) for the New Drug Application (NDA) of the cancer-fighting drug quizartinib.

FDA panel: more research needed on potentially negative effects associated with paclitaxel-coated device treatment

By Bram Berkowitz | Jul 8, 2019

While the long-term effects of treatment with paclitaxel-coated devices in the peripherals are still unclear, the U.S. Food and Drug Administration could not rule out an association with adverse effects, even at very low drug concentrations.

BIOTRONIK: Receives FDA Clearance on Next-Gen Injectable Cardiac Monitor: BIOMONITOR III

By Press release submission | Jul 8, 2019

Device is 60% Smaller, Offers Simplified One-Step Injection Procedure and Sets New Standard for Signal Quality

Cybersecurity issues lead to recall of some Medtronic insulin pumps

By Keri Carbaugh | Jul 6, 2019

Medtronic MiniMed 508 and MiniMed Paradigm series insulin pumps are being recalled because of cybersecurity concerns, according to the Food and Drug Administration.

INSYS THERAPEUTICS, INC: FDA Accepts New Drug Application for INSYS Therapeutics’ Naloxone Nasal Spray for the Emergency Treatment of Known or Suspected Opioid Overdose

By Press release submission | Jul 5, 2019

INSYS Therapeutics, Inc. (OTCMKTS: INSYQ), announced that its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational, proprietary naloxone nasal spray for the emergency treatment of known or suspected opioid overdose in both adult and pediatric patients has been accepted for filing.

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