Onyx Pharmaceuticals this afternoon issued an announcement summarizing its full year and fourth quarter 2011 financial results.

Company man­agement also discussed the firm's financial results and near-term plans in an analyst conference call later in the day.

Contrary to speculation by some analysts, today's announcement and man­agement discussion did not provide any significant new in­­for­ma­tion about the ongoing review by the U.S. Food and Drug Administration (FDA) of carfilzomib (Kyprolis).

Onyx (NASDAQ: ONXX) has submitted a new drug application to the FDA asking it to approve car­filz­o­mib as …

Celgene announced this morning that it plans to submit an application for the approval of pomalidomide for relapsed and refractory multiple myeloma to the U.S. Food and Drug Administration (FDA) during the first quarter of 2012.

In addition, the company said that it plans to submit a similar application to the European Medicines Agency (EMA) during the first half of this year.

The updated submission timeline means that pomalidomide could be approved for use in the United States and in Europe by the end of this year.

Celgene's announcement was made in a …

Onyx Pharmaceuticals, the U.S. com­pany developing car­filz­o­mib as a potential new treat­ment for multiple myeloma, announced earlier today that the U.S. Food and Drug Administration (FDA) has granted "standard review designation" to the com­pany's New Drug Applica­tion for car­filz­o­mib.

This means that the FDA expects to make a decision by July 27, 2012, on Onyx's application to market carfilzomib (Kyprolis) in the United States.

The announcement is a disappointment for Onyx, which had hoped to receive a so-called "priority review" of the car­filz­o­mib application.

The target FDA review time for applications granted …

Onyx Pharmaceuticals, the U.S. com­pany developing car­filz­o­mib as a potential new treat­ment for multiple myeloma, announced this morning that the U.S. Food and Drug Administration (FDA) has accepted the com­pany's New Drug Applica­tion for car­filz­o­mib.

The announcement means that the FDA will now begin its full review of carfilzomib (Kyprolis).

The length of time required for that review depends on whether the FDA grants the drug what is known as "priority review."

If car­filz­o­mib is granted priority review, the FDA will aim to make a decision on the application by the …

The U.S. Food and Drug Administration (FDA) announced last week that it is investigating the safety of the multiple myeloma drugs Revlimid and thalidomide.  The Beacon covered this development in an earlier article.  More details are provided here about why the FDA is conducting the investigation and the possible outcomes of that investigation.  These questions and answers have been developed in consultation with the FDA.

Why is the FDA investigating the safety of Revlimid and thalidomide?

In December, intermediate results from three clinical trials studying long-term use of Revlimid …

The U.S. Food and Drug Administration (FDA) earlier today issued a formal announcement that it is investigating the safety of  the multiple myeloma treatments Revlimid and thalidomide. 

The investigation is being carried out due to clinical trial results that suggest Revlimid may increase the risk of secondary cancer in patients taking the drug for extended periods of time.

The announcement confirms a Beacon news update last week that reported evidence that an investigation of Revlimid was underway (see related Beacon news).

Today's FDA statement says that the agency is "aware of results from clinical trials ... that have found that patients treated with