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First and only medicines approved for patients with either wild-type or hereditary transthyretin amyloid cardiomyopathy
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Erlotinib Hydrochloride Tablets treat metastatic non-small cell lung and pancreatic cancers
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
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.
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.
An additional treatment modality would provide more flexibility in how patients receive vedolizumab, a biologic with a gut-selective mode of action
Robust Clinical Evidence Supports PREVENATM Therapy Effectiveness in Reducing SSIs in a Range of Medical Specialties
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.
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).
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.
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.
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).
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.
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.
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.
Measles is one of the most contagious respiratory diseases in the world that has the potential to be life-threatening.
FDA announces new efforts to protect women's heath and ensure the safety of breast implants
Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the launch of its newly redesigned website for Qudexy® XR (topiramate) Extended-Release Capsules.
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
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