Thursday, April 2, 2020

Thursday, April 2, 2020

Latest News

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

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.

New campaign seeks to remove opioids from the home

The Food and Drug Administration is looking to women aged 35-64 to “Remove the Risk” of opioids in the household.

FDA moves to reduce risks associated with surgical staplers and implantable stables

The Medical Device Safety Action plan outlines the FDA’s mission to protect public health in a more timely and effective way.

Clinical drug trial costs 'surprisingly low,' Johns Hopkins researchers find

Contrary to past drug company pronouncements, the cost of clinical trials makes up a small fraction of pharmaceutical drug development costs, a new study concludes.

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

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

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

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

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

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

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

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

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

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

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

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: FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis

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: FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

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.

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

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).

Approval of device to treat ADHD welcomed, with some caution

Parents, doctors and other stakeholders are welcoming the approval of a device to help treat children of a certain age with attention-deficit/hyperactivity disorder (ADHD), but with caution.

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

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.

OPTINA DIAGNOSTICS: Receives Breakthrough Device Designation from U.S. FDA for a Retinal Imaging Platform to Aid in the Diagnosis of Alzheimer's Disease

Optina Diagnostics announces today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its retinal imaging platform (CAPRS1/MHRC2).

7 drugs recalled during April, FDA reports

Seven drugs were recalled in April to protect patients from possible harmful defects associated with the products, the U.S. Food and Drug Administration reported.

FDA Health News