The FDA scheduled an advisory committee meeting on July 26 to discuss the ocriplasmin BLA and assigned a PDUFA date of Oct. 17

In other news, Celgene reported that its new drug application for pomalidomide plus low-dose dexathasone in patients with relapsed and refractory multiple myeloma was accepted for standard review by the FDA, with a PDUFA date of Feb. 10, 2013

Its PDUFA date will be Feb. 24, 2013

In other news, Celgene reported that its new drug application for pomalidomide plus low-dose dexathasone in patients with relapsed and refractory multiple myeloma was accepted for standard review by the FDA, with a PDUFA date of Feb. 10, 2013

The FDA has provided an anticipated PDUFA date of Nov. 21

Gilead Sciences Inc., of Foster City, Calif., said the FDA extended the PDUFA date to Sept

The CHMP hearing was delayed at Vivus' request, so the company could focus on working with the FDA ahead of Qnexa's July 17 PDUFA date and prepare for a potential U.S

Talon Therapeutics Inc., of San Mateo, Calif., said the FDA extended its PDUFA date for Marqibo (vincristine sulfate liposomes injection) by three months, until August 12

Salix Pharmaceuticals Ltd., of Raleigh, N.C., said the FDA extended by three months the PDUFA date for its priority review of the new drug application for crofelemer for the control and symptomatic relief of diarrhea in patients with HIV/AIDS on antiretroviral therapy...The new PDUFA date is Sept

The PDUFA date for carfilzomib is July 27

Salix Pharmaceuticals Ltd., of Raleigh, N.C., and Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., said the FDA extended the PDUFA date by three months for Relistor (methylnaltrexone bromide) injection for subcutaneous use for the treatment of opioid-induced constipation in adults with chronic, noncancer pain...The new PDUFA date is June 27, 2012

Mirabegron's PDUFA date is June 29...The FDA set a PDUFA date of Aug. 4

Mirabegron's PDUFA date is June 29

Navidea Biopharmaceuticals Inc., of Dublin, Ohio, said the FDA extended the PDUFA date for Lymphoseek (99m-Tc-Tilmanocept) by 90 days, to Sept...10, after the company provided updated chemistry, manufacturing and control information requested by the agency within the 90-day period prior to the original PDUFA date

The resubmitted application has a PDUFA date of June 27

Northera has a PDUFA date of March 28. (See BioWorld Today, Feb. 14, 2012, and Feb. 24, 2012

Cornerstone Therapeutics Inc., of Cary, N.C., said the FDA accepted its new drug application for CRTX 080 in hyponatremia and assigned a PDUFA date of Oct. 29

The agency assigned a PDUFA date of Oct. 22

The product is under priority review at the FDA, with a PDUFA date of June 21