The U.S. Food and Drug Administration (FDA) is giving itself an extra two to three months to decide whether to approve panobinostat as a new treatment for mul­ti­ple myeloma.

The FDA had been expected to reach a decision on the panobinostat new drug application by last Tuesday.  Now, however, a decision is unlikely to occur until the end of November or sometime in December.

The Swiss pharmaceutical company Novartis (NYSE:NVS) filed an ap­pli­ca­tion with the FDA in March to have panobinostat, in combination with Velcade (bortezomib) and

Panobinostat could be the next potential myeloma therapy approved by the U.S. Food and Drug Administration (FDA).

Moreover, an approval decision related to the drug's potential marketing in the United States could be made by this fall.

In a surprisingly indirect manner, Novartis, the Swiss pharmaceutical com­pany that is developing pan­o­bino­stat (LBH589), announced this morn­ing that it has filed an application to have pan­o­bino­stat approved as a new drug by the FDA.

The announcement was indirect in the sense that Novartis did not actually say it has filed an application for …

On Friday, the U.S. Food and Drug Administration (FDA) approved Pomalyst (pomalidomide) for the treatment of multiple myeloma patients who have received at least two prior therapies (see related Beacon news).

In this article, The Beacon addresses important questions multiple myeloma patients have been asking about the FDA decision.  The article is organized similarly to one the Beacon published about Kyprolis (carfilzomib) after it was approved by the FDA last summer.

What exactly did the FDA …

The United States Food and Drug Administration (FDA) has approved pomalidomide, which will be marketed under the brand name Pomalyst, for the treatment of relapsed and refractory multiple myeloma.

Specifically, Pomalyst has been approved for use in patients with multiple myeloma who have received at least two prior therapies including Rev­limid (lenalido­mide) and Velcade (bortezomib) and have demon­strat­ed disease progression on or within 60 days of completion of the last therapy.

Celgene (NASDAQ:CELG), the company that will market Pomalyst, has told The Beacon that the drug will be …

The "what will the FDA decide about pomalidomide" waiting game is reaching its final hours, and the drama is peaking.

Celgene (CELG:NASDAQ), the company that has been developing poma­lido­mide, asked the U.S. Food and Drug Administration (FDA) last April to approve the drug for the treatment of relapsed and refractory myeloma.

Based on the date the company filed its new drug application with the FDA, the regulator is required to make a decision on the application by this coming Sunday, February 10.

Financial analysts are expecting a positive decision by …

The U.S. Food and Drug Administration (FDA) has canceled the November advisory committee meeting during which Celgene's application to have pomalidomide (Pomalyst) approved as a new multiple myeloma treatment was scheduled to be reviewed.

The meeting of the advisory committee -- formally known as the Oncologic Drugs Advisory Committee (ODAC) -- was placed on the FDA schedule just last month (see related Beacon news).

The cancellation of the ODAC meeting does not necessarily mean there has been any change in either the FDA's overall schedule for reviewing pomalidomide's new drug …

Celgene announced this morning that the U.S. Food and Drug Administration has set a date for an advisory committee meeting to review the company’s application for approval of pomalidomide.

Celgene (NASDAQ: CELG) has applied to the Food and Drug Administration (FDA) to have pomalidomide (Pomalyst) approved, in combination with dexamethasone(Decadron), for the treatment of patients with relapsed and refractory multiple myeloma that has progressed after at least two prior therapies.

The Oncologic Drugs Advisory Committee (ODAC), which advises the FDA regarding the potential approval of new cancer drugs, will meet …