The application includes data from the open-label, Phase 2 VE-BASKET study; non-randomized, basket study investigating the use of Zelboraf in patients with BRAF V600 mutation-positive cancers and other diseases, including 22 patients with ECD.
Synthetic Biotic medicines utilize synthetic biology to reprogram probiotic bacteria to perform critical functions that compensate for those missing or damaged due to a particular disease.
The FDA will consider the Committee's recommendation before acting on the biologics license application (BLA) for the epoetin alfa biosimilar.
Patients taking apixaban showed significantly less intracranial hemorrhage (0.33% per year) vs. patients taking warfarin (0.80% per year) no matter the type and location.
Alexion has submitted a marketing application to the Food and Drug Administration (FDA) to extend the indication for Soliris (eculizumab) to be a treatment for patients with refractory generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.
Apellis has announced that the Food and Drug Administration (FDA) has granted Fast Track designation to APL-2, a novel drug candidate studied for the treatment of paroxysmal nocturnal hemoglobinuria (PNH)
At the 2016 American Society of Hematology (ASH) Annual Meeting, researchers from Janssen and Bayer presented data showing that cancer patients treated with Xarelto (rivaroxaban) for blood clots had significantly fewer emergency room (ER) visits and lower healthcare costs at start of therapy vs. patients given standard treatment.
Following an 11-month shortage, the Food and Drug Administration (FDA) has announced that Agrylin (anagrelide HCl; Shire) 0.5mg capsules are now available.
In a clinical practice guideline published online Octocber 12 in the Journal of the American Medical Association, recommendations are presented for the target hemoglobin level for red blood cell (RBC) transfusion and optimal duration of RBC storage.
For patients with hereditary angioedema due to C1-inhibitor deficiency (C1-INH-HAE), those with bacteriuria have a higher number of edematous attacks, according to a study published online in Allergy.