NPS Pharmaceuticals, Inc.(NASDAQ: NPSP) confirmed that it has been assigned a PDUFA date of September 30, 2012 for Gattex for the treatment of adult short bowel syndrome or SBS. It also intends  to submit to the FDA a Biologics License Application (BLA) for Natpara toward the end of 2012 as the first replacement therapy for hypoparathyroidism. Protalix BioTherapeutics, Inc. (NYSE Amex:PLX) [...]

BioSante Pharmaceuticals Inc. (NASDAQ: BPAX) - The FDA said today that it approved Bio-T-Gel, a once-daily transdermal testosterone gel in development for the treatment of male hypogonadism, or low testosterone levels. Santarus, Inc. (NASDAQ: SNTS) today announced the FDA has accepted for filing its New Drug Application (NDA) for UCERIS for the induction of remission of mild to moderate [...]

Amarin Corporation plc (Nasdaq:AMRN) said that it has been informed by the FDA that no advisory committee meeting will be scheduled for its New Drug Application (NDA) of AMR101 in the treatment of patients with very high triglycerides, currently scheduled for review on July 26, 2012. Celsion Corporation (NASDAQ: CLSN) announced today that the first patient has been [...]

Insmed Incorporated (Nasdaq: INSM) said today that it intends to initiate a Phase 2 trial  in mid-2012 of ARIKACE in patients with non-tuberculous mycobacteria (NTM) lung disease. It noted that its clinical hold previously placed on the ARIKACE clinical study in CF patients with Pa lung infections continues, following ongoing discussions with the FDA. Exelixis, Inc.(Nasdaq:EXEL) priced its offering [...]

Astex Pharmaceuticals, Inc. (NASDAQ:ASTX) today announced that the FDA Oncologic Drugs Advisory Committee (ODAC) voted 10 to 3 with one person abstaining that data in the supplemental new Drug Application (sNDA) for DACOGEN for Injection did not support a favorable benefit-risk profile for the treatment of acute myeloid leukemia (AML) in adults 65 years of age or [...]

Neurocrine Biosciences, Inc. (NASDAQ: NBIX) gave a pipeline update today noting that it expects to initiate its Phase 3 trial of elagolix for endometriosis during 1H 2012. It also expects data from its second Phase 2 trial of NBI-98854 in tardive dyskinesia patients during March 2012. A larger Phase 2b program is planned to be initiated during 2012. Topline data [...]