Regulatory News for February 2010

FDA committee recommends XIFAXAN® approval for hepatic encephalopathy

The Gastrointestinal Drugs Advisory Committee of the FDA has recommended the approval of XIFAXAN® (rifaximin) tablets (550 mg) for the maintenance of remission of hepatic encephalopathy.
24 February, 2010

Silence Therapeutics receives notice of allowance for RNAi patent

Silence Therapeutics announced recently that the United States Patent and Trademark Office has issued them a notice of allowance on a patent application covering a novel cancer target.
10 February, 2010

FDA approves Xiaflex for debilitating hand condition

Xiaflex has recently been approved to treat progressive hand disease Dupuytren's contracture, which can affect a person’s ability to straighten and use their fingers.
05 February, 2010

FDA approves Victoza® (liraglutide) for diabetes

Novo Nordisk has announced that the FDA has granted marketing authorization for Victoza® for the treatment of type 2 diabetes in adults.
02 February, 2010

Advice highlights risk of Automatic Generic Substitution

A drug safety warning from the MHRA on the dangers of switching immunosuppressants calls into question the safety of the Department of Health’s proposal for Automatic Generic Substitution.
01 February, 2010

Regulatory News Archive

FDA committee recommends XIFAXAN® approval for hepatic encephalopathy FDA committee recommends XIFAXAN® approval for hepatic encephalopathy

Silence Therapeutics receives notice of allowance for RNAi patent Silence Therapeutics receives notice of allowance for RNAi patent

FDA approves Xiaflex for debilitating hand condition FDA approves Xiaflex for debilitating hand condition

FDA approves Victoza® (liraglutide) for diabetes FDA approves Victoza® (liraglutide) for diabetes

Advice highlights risk of Automatic Generic Substitution Advice highlights risk of Automatic Generic Substitution

FDA committee recommends XIFAXAN® approval for hepatic encephalopathy

Silence Therapeutics receives notice of allowance for RNAi patent

FDA approves Xiaflex for debilitating hand condition

FDA approves Victoza® (liraglutide) for diabetes

Advice highlights risk of Automatic Generic Substitution