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Novartis announces FDA approval of Entresto to reduce risk of...
2015-07-09 05:43:33| Biotech - Topix.net
Novartis announced today that the US Food and Drug Administration has approved Entresto tablets, previously known as LCZ696, to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure and reduced ejection fraction . It is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin receptor blocker .
FDA Warns Pharmagel
2015-07-07 22:00:00| Happi Breaking News
Several products said to make drug claims
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warns
fda warns
warns fda
Clot risk in Lilly lung-cancer drug raises FDA concerns
2015-07-07 21:33:35| Biotech - Topix.net
Eli Lilly and Co.' s experimental lung cancer drug has raised concerns with U.S. regulators that it may increase patients' risk of suffering potentially deadly blood clots.
Tags: risk
drug
concerns
raises
Watchdog urges FDA to revoke approval of Genzyme surgical implant
2015-07-07 16:23:17| Biotech - Topix.net
REUTERS: Consumer watchdog Public Citizen said it petitioned the U.S. health regulators to withdraw approval of Sanofi SA's Seprafilm and order a recall, saying the surgical implant has been associated with side effects including death. Seprafilm, developed by Genzyme, is used to reduce abnormal internal scarring following surgery, by separating tissues and organs while they heal.
Tags: approval
surgical
fda
urges
Akcea Therapeutics obtains FDA Orphan Drug Designation for volanesorsen
2015-07-06 15:29:07| Biotech - Topix.net
Akcea Therapeutics, a wholly-owned subsidiary of Isis Pharmaceuticals, Inc. , announced today that the U.S. Food and Drug Administration has granted Orphan Drug Designation to volanesorsen for the treatment of patients with Familial Chylomicronemia Syndrome . FCS is a rare genetic disease characterized by extremely high triglyceride levels and risk of pancreatitis.
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designation
fda
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