Today, the U.S. Food and Drug Administration approved Strensiq (asfotase alfa) as the first approved treatment for perinatal, infantile and juvenile-onset hypophosphatasia (HPP).
Category Archives: Drug Safety Information Podcasts
FDA approves new therapy for certain types of advanced soft tissue sarcoma
The U.S. Food and Drug Administration today approved Yondelis (trabectedin), a chemotherapy, for the treatment of specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who previously received chemotherapy that contained anthracycline.
FDA approves new treatment for advanced pancreatic cancer
The U.S. Food and Drug Administration today approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with advanced (metastatic) pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy.
FDA approves new drug to treat hyperkalemia
The U.S. Food and Drug Administration today approved Veltassa (patiromer for oral suspension) to treat hyperkalemia, a serious condition in which the amount of potassium in the blood is too high.
US Marshals seize adulterated crab products for food safety violations
At the request of the U.S. Food and Drug Administration and the U.S. Attorney for the District of Massachusetts, U.S. Marshals have seized about 5,000 cases of ready-to-eat frozen Jonah crab products processed by Rome Packing Company Inc. (Rome Packing). FDA investigators determined the products have been prepared, packed and held under unsanitary conditions and may present a risk to human health.
FDA approves first Factor X concentrate to treat patients with rare hereditary bleeding disorder
The U.S. Food and Drug Administration today approved Coagadex, Coagulation Factor X (Human), for hereditary Factor X (10) deficiency. Until today’s orphan drug approval, no specific coagulation factor replacement therapy was available for patients with hereditary Factor X deficiency.
FDA approves Praxbind, the first reversal agent for the anticoagulant Pradaxa
The FDA has 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.
FDA expands approved use of Opdivo in advanced lung cancer
The U.S. Food and Drug Administration today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy.
FDA allows marketing of the first nucleic acid-based test to detect multiple pathogens from a single sample of cerebrospinal fluid
The U.S. Food and Drug Administration today allowed marketing of the first cerebrospinal fluid (CSF) nucleic acid-based test for simultaneous detection of multiple pathogens that can cause central nervous system infections.
Federal judge issues permanent injunction against South Dakota laser manufacturer
A federal judge in the U.S. District Court for the District of South Dakota yesterday granted the U.S. Food and Drug Administration a permanent injunction against 2035 Inc. and Robert “Larry” Lytle, doing business as QLasers PMA and 2035 PMA.