October 26, 2015
Medicine for treating pancreatic cancer approved in US
The U.S. Food and Drug Administration has approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat…
Pharmaceuticals, Biotechnology and Life Sciences
Tag: FDA
October 19, 2015
Shire disappointed, wating lifitegrast, OPUS-3 study, data
“We were disappointed, but will soon have data from the Phase 3 study, OPUS 3,” said Flemming Ornskov, M.D., CEO, Shire.
October 16, 2015
FDA: Blood thinners can prevent strokes
Blood thinner (anticoagulant) can reduce the risk of a stroke by 50% to 60% for people who have atrial fibrillation.
October 16, 2015
FDA approved Praxbind for patients taking Pradaxa
The U.S. Food and Drug Administration on Friday granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.
October 16, 2015
USA:Recall of lot # 45810 of Acetaminophen tablets
Medline Industries, Inc. announced that it will initiate a voluntary nationwide recall of lot # 45810 of Acetaminophen tablets, 500mg, uncoated compressed tablets to the consumer level.
October 13, 2015
FDA: Skipanon Brand Seafoods LLC Recalls all Seafood Canned Products
Skipanon Brand Seafoods LLC of Warrenton, Oregon is voluntarily recalling ALL LOTS, ALL SIZES of ALL Skipanon brand seafoods canned products because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.
October 12, 2015
FDA: Opdivo approved for treating patients with advanced non-small cell lung cancer
The U.S. Food and Drug Administration (FDA) has today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy.
October 9, 2015
FDA Accepts Allergan’s Supplemental New Drug Application (sNDA) for DALVANCE
Allergan plc has announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Allergan’s supplemental New Drug Application (sNDA), for MRSA.
October 8, 2015
US FDA announces updated drug shortages list
U.S. Food & Drug Administration (FDA) has updated information on Drug Shortages.
October 8, 2015
Lilly Receives FDA Breakthrough Therapy Designation for Abemaciclib in Advanced Breast Cancer
Eli Lilly and Company has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to…