U.S. Food and Drug Administration’s ongoing efforts to address the coronavirus outbreak (COVID-19), the agency issued a new policy that allows manufacturers of certain FDA-cleared non-invasive, vital sign-measuring devices to expand their use so that health care providers can use them to monitor patients remotely.
The FDA previously approved Epclusa to treat HCV in adults.
FDA Grants Priority Review and sets PDUFA Date of August 13, 2020
Application is based on positive data from the Phase 3 CANDOR study, which were presented at the 2019 American Society of Hematology Annual Meeting
RRP is a rare, potentially fatal orphan disease caused by Human Papillomavirus (HPV) 6 and 11
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.
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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
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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).
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.
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Approval Based on Robust Clinical Development Program That Included Two Pivotal Trials of Nearly 2,000 Patients
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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.
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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.
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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).
Joint FDA/ASH Led Initiative Highlights Importance of Using Patient Reported Outcomes and Biomarkers in Clinical Trials to Advance SCD Therapies