U.S. Food and Drug Administration 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.
In consultation with the U.S. Food and Drug Administration (FDA), the U.S. Product Inserts (USPI) for VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) and TECHNIVIE™ (ombitasvir, paritaprevir, and ritonavir tablets) have been updated from 'not recommended in Child Pugh B patients' to a contraindication in patients with Child-Pugh B cirrhosis. The updated USPI for VIEKIRA PAK also includes a recommendation for physicians to assess evidence of hepatic decompensation prior to treatment and during treatment in cirrhotic patients.
Alexion Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Strensiq (asfotase alfa) for the treatment of patients with perinatal-, infantile- and juvenile-onset hypophosphatasia (HPP).
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US Food and Drug Administration’s (FDA) Arthritis Advisory Committee (AAC) voted 10 to 4 to recommend the approval of lesinurad 200mg tablets for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor (XOI). All 10 who backed the drug, lesinurad, qualified their vote by urging the FDA to ask AstraZeneca for studies after the drug's launch to gauge its long-term effectiveness and safety.
Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Tramadol Hydrochloride Extended -release Tablets USP, 100 mg, 200 mg and 300 mg.
There is good news for people suffering from hair loss. In experiments with mouse and human hair follicles, researchers have found that certain existing drugs promote rapid and robust hair growth when directly applied to the skin.
Some Imported Dietary Supplements and Nonprescription Drug Products May Harm You.
Just because a product claims to be natural doesn’t necessarily mean it’s safe, says Gary Coody, R. Ph., FDA’s national health fraud coordinator. Likewise, just because a product claims to be natural does not mean that it’s free of hidden drug ingredients.
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.
Edwards Lifesciences Corporation, a global leader in the science of heart valves and hemodynamic monitoring, has received US Food and Drug Administration (FDA) approval for aortic valve-in-valve procedures using the Edwards Sapien XT transcatheter heart valve.
Pfizer's investigational antibody-drug conjugate (ADC) inotuzumab ozogamicin received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for acute lymphoblastic leukemia (ALL).
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