Tuesday, May 14, 2024

Tuesday, May 14, 2024

Latest News

BIOTIME, INC.: Announces Issuance of U.S. Patent for Method of Reducing Cavitation in Patients with Acute Spinal Cord Injury

Patients

By Press release submission | May 7, 2019

BioTime, Inc. (NYSE American and TASE: BTX), a clinical-stage biotechnology company developing cellular therapies for unmet needs, announced today the issuance of a Notice of Allowance for a patent from the United States Patent and Trademark Office (USPTO) for United States Patent Application No. 15/156,316 for a method of reducing spinal cord injury (SCI)-induced parenchymal cavitation in patients that have suffered an acute spinal cord injury.

SAVARA, INC.: Announces Molgradex Received Fast Track Designation by FDA for Treatment of Autoimmune Pulmonary Alveolar Proteinosis

FDA Approval

By Press release submission | May 7, 2019

Savara Inc. (NASDAQ: SVRA), an orphan lung disease company, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF).

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

Patients

By Press release submission | May 6, 2019

The U.S. Food and Drug Administration today approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to less than 17 years of age.

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis

Patients

By Press release submission | May 6, 2019

On May 3, the U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults.

U.S. FOOD AND DRUG ADMINISTRATION: Life Rising Corporation Recalls Chinese Herbal Supplements Because of Possible Health Risk

Regulation

By Press release submission | May 5, 2019

Life Rising Corporation of Willowbrook, IL is recalling Life Rising Holder-W Holder Warmer capsules, Life Rising NECK-ND Neck Clear capsules, and HoliCare Metabolism Cleansing (MET-CLS) tablets because the products have the potential to contain excessive levels of lead.

U.S. FOOD AND DRUG ADMINISTRATION: Vaccination Is the Best Protection Against Measles

Patients

By Press release submission | May 5, 2019

Measles is one of the most contagious respiratory diseases in the world that has the potential to be life-threatening.

ISAPS: Applauds U.S. FDA Allowance of Textured-Surface Breast Implant Sales

Patients

By Press release submission | May 4, 2019

FDA announces new efforts to protect women's heath and ensure the safety of breast implants

UPSHER-SMITH LABORATORIES, INC.: Unveils Educational Resources And Support Tools For Migraine Patients

Patients

By Press release submission | May 4, 2019

Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the launch of its newly redesigned website for Qudexy® XR (topiramate) Extended-Release Capsules.

INVITAE CORPORATION: New Study From Invitae Highlights the Importance of Multigene Genetic Testing for Uterine Cancer Patients

Patients

By Press release submission | May 3, 2019

Results from one of the largest datasets in uterine cancer presented at The American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting

CARIS LIFE SCIENCES: Receives FDA Breakthrough Device Designation for MI Transcriptome™ Companion Diagnostic Test

FDA Approval

By Press release submission | May 3, 2019

This is the first companion diagnostic to detect gene fusions across all solid tumors; Caris expects to submit for Pre-Market Approval later this year

IVANTIS, INC.: Announces Groundbreaking 3 Year Results from FDA Clinical Trial; First Device in Minimally Invasive Glaucoma Surgical (MIGS) Category to Demonstrate Significant Long Term Reduction of Severe Major Surgeries for Glaucoma Patients

Patients

By Press release submission | May 2, 2019

First study of any kind showing a MIGS device achieving a statistically significant reduction in secondary incisional surgery; over 70% of patients remain free of medications

U.S. FOOD AND DRUG ADMINISTRATION: First FDA-approved vaccine for the prevention of dengue disease in endemic regions

FDA Approval

By Press release submission | May 1, 2019

The U.S. Food and Drug Administration announced today the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas.

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves device to help increase access to more lungs for transplant

FDA Approval

By Press release submission | Apr 29, 2019

The U.S. Food and Drug Administration approved a device, called Xvivo Perfusion System with Steen Solution Perfusate, that can temporarily ventilate, oxygenate, and pump (perfuse) preservation solution through lungs that were initially thought to be unacceptable for transplant.

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first treatment for pediatric patients with lupus

FDA Approval

By Press release submission | Apr 29, 2019

The U.S. Food and Drug Administration approved Benlysta (belimumab) intravenous (IV) infusion for treatment of children with systemic lupus erythematosus (SLE) – often referred to as simply “lupus”

NEUROSIGMA, INC.: Announces FDA Clearance of Monarch eTNS System as First Non-Drug Treatment for Pediatric ADHD

Regulation

By Press release submission | Apr 26, 2019

NeuroSigma, Inc., a Los Angeles-based bioelectronics company focused on commercializing Trigeminal Nerve Stimulation (TNS) technology for treating neurological and neuropsychiatric disorders announced that its Monarch® eTNS® System (Monarch) received FDA clearance as a non-drug treatment for attention deficit hyperactivity disorder (ADHD).

ABBVIE: Expands Immunology Portfolio in the U.S. with FDA Approval of SKYRIZI™ (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis

FDA Approval

By Press release submission | Apr 26, 2019

Approval based on clinical trials showing people treated with SKYRIZI™ (risankizumab-rzaa) every 12 weeks - four doses a year after two initial doses - achieved high levels of durable skin clearance at 16 weeks and maintained this response at one year[1-3]

BOSTON SCIENTIFIC CORPORATION: Receives FDA Approval for LOTUS Edge™ Aortic Valve System

FDA Approval

By Press release submission | Apr 25, 2019

Transcatheter Aortic Valve Replacement Technology for Patients with Severe Aortic Stenosis Designed to Minimize Paravalvular Leakage, Offer Controlled Delivery and Repositionability Post Deployment

ALIVECOR: FDA Grants First-Ever Clearances to Detect Bradycardia and Tachycardia on a Personal ECG Device

FDA Approval

By Press release submission | Apr 25, 2019

KardiaMobile® Now The Only Personal ECG to Detect The Three Most Common Heart Arrhythmias

LONGHORN VACCINES AND DIAGNOSTICS LLC: PrimeStore® MTM opens Sputum-free Molecular Screening for M. tuberculosis Infection

Patients

By Press release submission | Apr 24, 2019

South Africa pilot study demonstrates new broad approach to identifying M. tuberculosis infected patients for further clinical investigation and treatment

VETOQUINOL USA: Launches Flexprofen™

FDA Approval

By Press release submission | Apr 24, 2019

Generic carprofen chewable tablet developed to treat osteoarthritis symptoms in dogs

Trending

  1. 1 TONGLIAN GROUP: Innovative drug, Carrimycin, Receives FDA Approval for International, Multi-country Phase III Clinical Trial for the treatment of severe COVID-19 in hospitalized patients
  2. 2 UROVANT SCIENCES: Announces U.S. FDA Approval of GEMTESA® (vibegron) 75 mg Tablets for the Treatment of Patients with Overactive Bladder (OAB)
FDA Health News