icometrix announced today that the FDA has allowed the clinical use of their icolung AI algorithms for fast and objective quantification of lung pathology on chest CT scans in admitted COVID-19 patients.
First of its kind AI-guided imaging supports assessment of cardiac function and decreases personnel exposure to novel Coronavirus
Accurate Diagnostic Labs, in collaboration with RUCDR Infinite Biologics, will continue to significantly increase active infection testing access to the country, as the FDA has cleared the groundbreaking saliva collection methodology to be used at home by patients, at the request of their health care provider.
The U.S. Food and Drug Administration took important actions to help accelerate the development of prevention and treatment options for COVID-19 by providing new guidance with recommendations for innovators and researchers conducting work in this area.
U.S. Food and Drug Administration authorized the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing.
Fast Track Designation Highlights the Urgent Need for New Heart Failure Treatment Options
The U.S. Food and Drug Administration approved Tabrecta (capmatinib) for the treatment of adult patients with non-small cell lung cancer (NSCLC) that has spread to other parts of the body.
Bexion Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted the company Orphan Drug Designation for its proprietary drug, BXQ-350, for the treatment of malignant glioma, including diffuse intrinsic pontine glioma (DIPG).
DarioHealth Corp. (Nasdaq: DRIO), a global digital therapeutics (DTx) innovator, announced today that in an effort to reduce contact between healthcare providers and patients in hospital settings, limit COVID-19 exposure, and preserve personal protective equipment (PPE), the U.S. Food and Drug Administration (FDA) has recognized that home-use blood glucose meters including Dario's smartphone-connected metering device may be used by patients with diabetes who are hospitalized due to COVID-19 to check their own blood glucose levels and provide the readings to the health care personnel caring for them.
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The U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets for adults with heart failure with reduced ejection fraction to reduce the risk of cardiovascular death and hospitalization for heart failure.
Mitsubishi Tanabe Pharma America, Inc. (MTPA) today reported that more than 5,000 people with amyotrophic lateral sclerosis (ALS) have received the treatment with RADICAVA® (edaravone) in North America since the therapy was approved by the U.S. Food and Drug Administration (FDA) on May 5, 2017.
New Restylane HA Filler lasts for up to 1 year[1],[2] using XpresHAn Technology™
DARZALEX FASPRO™ is the only subcutaneous CD38-directed antibody approved in the treatment of multiple myeloma
Fensolvi is the only six-month, subcutaneously administered leuprolide acetate approved for the treatment of pediatric patients two years of age and older with Central Precocious Puberty
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced that it was granted U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the company’s SARS-CoV-2 Total Ab test, the first total antibody test receiving EUA from the FDA.
GlaxoSmithKline plc issued the following announcement on April 29.GlaxoSmithKline plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) approved the company's supplemental New Drug Application (sNDA) for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status.
The U.S. Food and Drug Administration granted marketing authorization for a new device indicated to provide continuous hemodialysis or hemofiltration therapy to critically ill pediatric patients weighing between 2.5 and 10 kilograms (or 5.5 to 22 pounds).
Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for JUBLIA® (efinaconazole) topical solution, 10%, a treatment for onychomycosis, a fungal infection of the toenails, which extends the age range included in the product's label to children six years of age and older.
A new paper in AACC's Clinical Chemistry journal outlines recommendations for labs
