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.
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
DARZALEX FASPRO™ is the only subcutaneous CD38-directed antibody approved in the treatment of multiple myeloma
New Restylane HA Filler lasts for up to 1 year[1],[2] using XpresHAn Technology™
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.
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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.
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.
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).
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.
Fast Track Designation Highlights the Urgent Need for New Heart Failure Treatment Options
U.S. Food and Drug Administration authorized the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing.
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.
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.
First of its kind AI-guided imaging supports assessment of cardiac function and decreases personnel exposure to novel Coronavirus
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.
If approved, AR19 would be the first-ever FDA-approved ADHD stimulant medication designed to resist manipulation for nonmedical use, which may help to deter misuse and abuse by intranasal, intravenous and smoking routes of administration
Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers and infectious diseases, announced today the FDA acceptance of the IND application for an allogeneic iNKT therapy, agenT-797, submitted by its subsidiary, AgenTus Therapeutics.
Clinical trials to begin at Miami Cancer Institute and Sanford Health
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Allergan cited for failure to comply with post-approval study requirements; Ideal Implant Inc. cited for failures relating to quality system and medical device reporting regulations
