SUBA™-Itraconazole to be Tested in Combination with Standard of Care Chemotherapy for Metastatic Castrate Resistant Prostate Cancer
U.S. Food and Drug Administration (FDA) approved Tepezza (teprotumumab-trbw) for the treatment of adults with thyroid eye disease, a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outwards (proptosis).
OBI PHARMA: Granted FDA Orphan Drug Designation for the Treatment of Pancreatic Cancer for Its Antibody-Drug Conjugate (ADC) Targeted Cancer Therapy, OBI-999
First Orphan Drug Designation for OBI-999, a novel first-in-class Antibody-Drug Conjugate targeting Globo H, a glycolipid antigen found on multiple tumor types
The U.S. Food and Drug Administration approved Ubrelvy (ubrogepant) tablets for the acute (immediate) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults.
EISAI INC.: U.S. FDA Approves Eisai's DAYVIGO™ (lemborexant) for the Treatment of Insomnia in Adult Patients
Approval Based on Robust Clinical Development Program That Included Two Pivotal Trials of Nearly 2,000 Patients
U.S. Food and Drug Administration granted accelerated approval to Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody and microtubule inhibitor conjugate, meaning the drug specifically targets cancer cells – in this case, the cell adhesion molecule Nectin-4, which is highly expressed in urothelial cancers.
U.S. FDA: FDA approves use of drug to reduce risk of cardiovascular events in certain adult patient groups
The U.S. Food and Drug Administration approved the use of Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels (a type of fat in the blood) of 150 milligrams per deciliter or higher.
U.S. FDA: FDA authorizes first interoperable, automated insulin dosing controller designed to allow more choices for patients looking to customize their individual diabetes management device system
The U.S. Food and Drug Administration authorized marketing of the Tandem Diabetes Care Control-IQ Technology, an interoperable automated glycemic controller device that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM).
AMERICAN SOCIETY OF HEMATOLOGY: ASH and FDA Unveil New Recommendations to Guide Clinical Development of Sickle Cell Disease Therapies
Joint FDA/ASH Led Initiative Highlights Importance of Using Patient Reported Outcomes and Biomarkers in Clinical Trials to Advance SCD Therapies
JANSSEN: Presents Initial Results for BCMA CAR-T Therapy JNJ-4528 Showing Early, Deep and High Responses in the Treatment of Relapsed or Refractory Multiple Myeloma
Results from Phase 1b/2 CARTITUDE-1 to premiere in oral presentation at ASH 2019 (Abstract #577)
U.S. FDA: Sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk
Liveyon Labs Inc. and Liveyon LLC warned that their stem cell products lack required FDA approval and represent a potential risk to the public health
U.S. FDA: FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases
The U.S. Food and Drug Administration today announced the global launch of CURE ID, an internet-based repository that will allow the clinical community to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing FDA-approved drugs through a website, a smartphone or other mobile device.
The U.S. Food and Drug Administration granted accelerated approval to Oxbryta (voxelotor) for the treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older.
Today the U.S. Food and Drug Administration granted approval to Reblozyl (luspatercept–aamt) for the treatment of anemia (lack of red blood cells) in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
ABBVIE: Submits Supplemental New Drug Application to U.S. FDA For IMBRUVICA® (ibrutinib) in Combination with Rituximab for the Treatment of Previously Untreated, Younger Adults with Chronic Lymphocytic Leukemia
Application is being reviewed under the FDA's Real-Time Oncology Review pilot program
TRANSTHERA BIOSCIENCES: Lead Product TT-00420 Granted Orphan Drug Designation from FDA to Treat Cholangiocarcinoma
TransThera Biosciences Co. Ltd, announced today that company received Orphan Drug Designation from US Food and Drug Administration (FDA) for TT-00420, a clinical stage investigational drug, for the treatment of cholangiocarcinoma.
EIP PHARMA: Announces U.S. FDA Grants Fast-Track Designation to Neflamapimod as a Treatment for Dementia with Lewy Bodies (DLB)
Phase 2 clinical trial of neflamapimod in patients with mild-to-moderate DLB currently enrolling patients in the U.S. and the Netherlands