KP1237, a CD38-Targeting Antibody Recruiting Molecule (ARM™), to Be Tested in Combination with NK Cells to Treat Post-Transplant Multiple Myeloma Patients
.jpg){kind=tracking}
Critical Milestone Reached in Response to this Outbreak
Pharmacosmos Therapeutics Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved Monoferric® (ferric derisomaltose) injection 100 mg/mL. Monoferric® is an intravenous iron indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have an intolerance to oral iron or have had unsatisfactory response to oral iron, or who have non-hemodialysis dependent chronic kidney disease.
Vizient, Inc. yesterday submitted comments to the Food and Drug Administration (FDA) in response to its draft guidance, “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.”
Arrevus today announced the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) Designation for ARV-1801 (sodium fusidate tablet) for the treatment of Cystic Fibrosis Pulmonary Exacerbations.
Teva Pharmaceuticals USA, Inc. an affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the Food and Drug Administration (FDA) has approved an autoinjector device for AJOVY® (fremanezumab-vfrm) injection.
This is a pivotal time in the field of gene therapy as the FDA continues its efforts to support innovators developing new medical products for Americans and others around the world.
If approved, Dupixent would be the first biologic medicine available in the U.S. for these children
On January 24, the Tuberous Sclerosis Alliance (TS Alliance) learned the US Food and Drug Administration (FDA) formally approved Lundbeck Pharmaceutical's label expansion for Sabril® (vigabatrin) to now be available to treat refractory complex partial seizures in patients 2 to 10 years old.
Today, the U.S. Food and Drug Administration (FDA) announced critical actions to advance development of novel coronavirus medical countermeasures.
.jpg){kind=tracking}
FDA working with manufacturer to assess scope of potential contamination risk, possible supply chain disruptions
.jpg){kind=tracking}
Abbott's Infinity™ DBS is the first FDA approved directional Deep Brain Stimulation (DBS) system to allow targeting of a specific area of the brain that is critical to motor functions
.jpg){kind=tracking}
U.S. Food and Drug Administration granted accelerated approval to Tazverik (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic (when cancer cells spread to other parts of the body) or locally advanced (when cancer has grown outside the organ it started in, but has not yet spread to distant parts of the body) epithelioid sarcoma not eligible for complete resection (surgically removing all of a tissue, structure, or organ).
ARU-1801 is being developed as a potential one-time treatment for patients suffering from sickle cell disease and β-thalassemia
.jpg){kind=tracking}
SUBA™-Itraconazole to be Tested in Combination with Standard of Care Chemotherapy for Metastatic Castrate Resistant Prostate Cancer
.jpg){kind=tracking}
Second Orphan Drug Designation for OBI-999, a novel first-in-class Antibody-Drug Conjugate in combination with a validated payload (MMAE) and the antibody targeting Globo H, a glycolipid antigen found on multiple tumor types.
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).
.jpg){kind=tracking}
TenNor Therapeutics, a clinical-stage, global biopharmaceutical company has received FDA Orphan Drug Designation for TNP-2092 to treat prosthetic joint infections.
.jpg){kind=tracking}
Outbreaks declared over, investigation advances, root cause analysis continues
LYNPARZA Reduced the Risk of Disease Progression or Death by 47% Compared to Placebo in Patients Whose Disease Had Not Progressed On at Least 16 Weeks of a First-Line Platinum-Based Chemotherapy Regimen. Only PARP Inhibitor Approved in Germline BRCA-mutated Advanced Pancreatic Cancer