Ensuring an efficient pathway to bring potentially lower-cost biosimilar and interchangeable protein products to market is key for expanding access to these products and increasing competition, ultimately helping American patients.
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 clears first fully disposable duodenoscope, eliminating the potential for infections caused by ineffective reprocessing
The U.S. Food and Drug Administration cleared for marketing in the U.S. the first fully disposable duodenoscope.
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).
AMGEN: FDA Approves Amgen's AVSOLA™ (infliximab-axxq), For The Same Indications As Remicade® (infliximab)
Amgen's Fourth FDA Approval From Biosimilars Portfolio
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.
LUMOSA THERAPEUTICS: Lumosa Announces FDA Acceptance of IND Application for LT1001, an Extended-Release Analgesic Injection - Lumosa to Initiate the Bridging Study in the US
LT1001 (brand name Naldebain®) is a prodrug of nalbuphine, an abuse-free analgesic that has been marketed worldwide for decades.
SK LIFE SCIENCE, INC.: Announces FDA Acceptance of IND Application for Anti-Epileptic Drug Candidate SKL24741
Acceptance of the IND application will allow the company to begin Phase I clinical trials for SKL24741 in 2020
U.S. FDA: FDA approves system for the delivery of ear tubes under local anesthesia to treat ear infection
The U.S. Food and Drug Administration approved a new system for the delivery of tympanostomy tubes, commonly referred to as ear tubes, that can be inserted into the eardrum to treat recurrent ear infections (i.e., otitis media).
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.
U.S. FDA: Statement on efforts to help make development of biosimilar and interchangeable insulin products more efficient
Access to affordable insulin can be a matter of life and death for Americans with diabetes. If not appropriately treated, diabetes can lead to serious and life-threatening complications, including heart disease, organ failure and blindness.
FDA Approves XCOPRI® (cenobamate tablets), an Anti-Epileptic Drug (AED) from SK Biopharmaceuticals, Co., Ltd., and U.S. Subsidiary SK Life Science, Inc.
XCOPRI is approved for the treatment of partial-onset seizures in adult patients
In Phase 2b development for the treatment of life-threatening fungal infections
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