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. (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).
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. (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 announces today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its retinal imaging platform (CAPRS1/MHRC2).
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.
Robust Clinical Evidence Supports PREVENATM Therapy Effectiveness in Reducing SSIs in a Range of Medical Specialties
.jpg){kind=tracking}
An additional treatment modality would provide more flexibility in how patients receive vedolizumab, a biologic with a gut-selective mode of action
Mavyret tablets were approved last week by the Food and Drug Administration for the treatment of all six genotypes of hepatitis C virus (HCV) in teenagers.
A McDonough, Georgia man who was the first to fight of a debilitating and deadly disease points out the reasons why “right to try” legislation that is being considered in North Carolina needs to succeed, according to a Washington Post op-ed piece.
SEP-363856 offers an innovative approach to the treatment of schizophrenia including the potential to be the first agent for the treatment of schizophrenia that does not bind to dopamine 2 (D2) receptors
.jpg){kind=tracking}
Erlotinib Hydrochloride Tablets treat metastatic non-small cell lung and pancreatic cancers
First and only medicines approved for patients with either wild-type or hereditary transthyretin amyloid cardiomyopathy
The U.S. Food and Drug Administration is now requiring its strongest warning to be used on several of the most commonly used prescription insomnia medicines.
EYLEA improves diabetic retinopathy and prevents worsening disease that can lead to blindness
Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved CYRAMZA® (ramucirumab injection, 10 mg/mL solution), as a single agent, for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha-fetoprotein (AFP) of ≥400 ng/mL and have been treated with sorafenib.
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) in combination with INLYTA® (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
If approved by the FDA, pexidartinib would be the first and only approved therapy for tenosynovial giant cell tumor (TGCT), which is associated with severe morbidity or functional limitations, and not amenable to improvement with surgery
Aidoc now leads the way in FDA approved AI solutions for radiologists
.jpg){kind=tracking}
POLYTECH Health & Aesthetics GmbH, a global leader in breast aesthetics, welcomes a recent statement by the FDA that textured breast implants will remain available in the US market, In opposition to the recent decision by the French health authority ANSM (Agence Nationale de Sécurité du Médicament) to ban 'macrotextured' and polyurethane coated implants from the French market.