SANFORD HEALTH: FDA approves COVID-19 trial after successful emergency use of umbilical stem cells from RESTEM
Clinical trials to begin at Miami Cancer Institute and Sanford Health
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AGENUS: FDA Clears AgenTus IND for Allogeneic iNKT Cell Therapy
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.
ARBOR PHARMACEUTICALS: Announces FDA Filing Acceptance of New Drug Application (NDA) for AR19, an Investigational ADHD Prescription Stimulant Treatment Specifically Designed to Resist Physical Manipulation for Nonmedical Misuse or Abuse
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
ICOMETRIX: FDA permits use of icometrix's AI-based quantification for chest CT in COVID-19
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.
CAPTION HEALTH: FDA Expedites Clearance of Caption Health Ultrasound Software to Aid Frontline Healthcare Workers in Fight Against COVID-19 Pandemic
First of its kind AI-guided imaging supports assessment of cardiac function and decreases personnel exposure to novel Coronavirus
ACCURATE DIAGNOSTIC LABORATORIES: Adds Another Weapon in the Fight Against COVID-19 as the FDA Clears the First Saliva Test for At-Home Use
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.
FDA: Coronavirus (COVID-19) Update: FDA Takes New Actions to Accelerate Development of Novel Prevention, Treatment Options for COVID-19
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.
FDA: Coronavirus (COVID-19) Update: FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens
U.S. Food and Drug Administration authorized the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing.
AMGEN: FDA Grants Fast Track Designation For Omecamtiv Mecarbil In Heart Failure
Fast Track Designation Highlights the Urgent Need for New Heart Failure Treatment Options
FDA: Approves First Targeted Therapy to Treat Aggressive Form of Lung Cancer
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: Receives Orphan Drug Designation for BXQ-350 for Malignant Glioma from FDA
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: Self-test Blood Glucose Meters Can Now Be Utilized Within Hospitals During the COVID-19 Pandemic Per Recently Issued Emergency FDA Guidelines
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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FDA: Approves new treatment for a type of heart failure
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: Marks Third Anniversary Of FDA Approval And Reports More Than 5,000 Patients With ALS Treated With RADICAVA® (edaravone)
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.
GALDERMA: Receives FDA Approval For Restylane® Kysse, A New Hyaluronic Acid (HA) Filler Specifically Designed And Indicated To Add Fullness To The Lips And Help Smooth The Wrinkles Above The Mouth
New Restylane HA Filler lasts for up to 1 year[1],[2] using XpresHAn Technology™
JANSSEN: U.S. Food and Drug Administration Approves DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj), a New Subcutaneous Formulation of Daratumumab in the Treatment of Patients with Multiple Myeloma
DARZALEX FASPRO™ is the only subcutaneous CD38-directed antibody approved in the treatment of multiple myeloma
TOLMAR PHARMACEUTICALS: FDA Approves FENSOLVI® (leuprolide acetate) for Injectable Suspension for Pediatric Patients with Central Precocious Puberty
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: Bio-Rad’s SARS-CoV-2 (COVID-19) Serology Test Granted FDA Emergency Use Authorization, the First Total Antibody Test to Receive EUA from the FDA
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.
GSK: FDA approves Zejula (niraparib) as the only once-daily PARP inhibitor in first-line monotherapy maintenance treatment for women with platinum-responsive advanced ovarian cancer regardless of biomarker status
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.