Biocon, which was down and beaten up past couple of days, was back in the reckoning today. From top loser two days ago, it was the top gainer since morning, going on to hit a new life-time high today at Rs.404.40 and is currently quoted at Rs.400 levels, up almost 9.5%.

The same US FDA which pushed the stock price into the red, was the reason for the upbeat mood today. The company’s breast cancer drug developed by itself and USA’s Mylan has received a favourable approval from the U.S. drug regulator’s advisory committee.

The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) unanimously recommended approval of the proposed biosimilar Trastuzumab, Biocon said in an exchange filing. The committee voted 16-0 in support of eligible indications of reference product Herceptin.

Bloomberg has explained that the drug regulator uses advisory committees and panels to obtain independent expert advice on a variety of matters, including product approvals. The FDA often follows the advice of ODAC in determining whether a product should come to market, although they are not required to follow it.