Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced that it has submitted its New Drug Application (NDA) for Staccato® loxapine (AZ-004) to the US Food and Drug Administration (FDA). AZ-004 is an inhalation product candidate being developed for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder. The IND for Staccato loxapine was filed [...]

ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops targeted anticancer therapeutics, reported encouraging clinical data with its IMGN901 product candidate in the treatment of relapsed and relapsed/refractory multiple myeloma (MM), including prolonged benefit in patients whose disease had progressed on multiple prior treatment regimens. These findings were reported at the American Society of Hematology [...]

Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, announced the publication of a poster(1) with new data from its ongoing phase 1 clinical trial of its product candidate blinatumomab in patients with non-Hodgkin’s lymphoma (NHL) at the 51ST Annual Meeting of the American [...]

Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV), a leading developer and marketer of specialty pharmaceutical products for pain management, today announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its investigational product candidate, Dyloject™ (diclofenac sodium) Injection, for the management of acute moderate-to-severe pain in adults. [...]

Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced that it is scheduled to meet with the U.S. Food and Drug Administration (FDA) on January 20, 2010 to discuss the Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). As previously announced, the Complete Response Letter, received by Transcept on October 28, [...]