Alexza Pharmaceuticals, Inc. announced today that it has resubmitted its AZ-004 New Drug Application (NDA) to the U.S. Food and Drug Administration in response to a Complete Response Letter (CRL) received in October 2010.

Morphotek®, Inc., a subsidiary of Eisai Inc., announced that it has commenced a multi-center, phase II study of MORAb-004 for the treatment of metastatic melanoma. The study will evaluate MORAb-004, a potentially first-in-class monoclonal antibody that specifically binds to endosialin/tumor endothelial marker-1 (TEM-1), as a single agent therapy comparing its ...

MOUNTAIN VIEW, Calif., Oct. 19 /- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA ) announced today that it has reacquired the U.S. and Canadian rights for AZ-004 (Staccato® loxapine) from Biovail Laboratories International SRL ("BLS"), a wholly-owned subsidiary of Valeant Pharmaceuticals International, Inc. (NYSE and TSX: VRX) ("Valeant").  AZ-004 is ...

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA or Agency) regarding its New Drug Application (NDA) for AZ-004 (Staccato® loxapine), submitted as Adusuve™ Staccato® (loxapine) inhalation aerosol, 5 mg and 10 mg. A ...

Valeant Pharmaceuticals International, Inc. announced today that Alexza Pharmaceuticals, Inc. has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding Alexza's New Drug Application (NDA) for AZ-004 (Staccato® loxapine) submitted as Adusuve™ Staccato® (loxapine) inhalation aerosol, 5 mg and 10 mg.

MISSISSAUGA, Ontario, Oct. 11 /- Valeant Pharmaceuticals International, Inc. (NYSE: VRX ) (TSX: VRX) announced today that Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA ) has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding Alexza's New Drug Application (NDA) for AZ-004 ...

MOUNTAIN VIEW, Calif., Oct. 11 /- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA ) announced today that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA or Agency) regarding its New Drug Application (NDA) for AZ-004 (Staccato® loxapine), submitted as Adusuve™ Staccato® (loxapine) ...

NEW ORLEANS , May 26 /- Results of clinical studies in patients with schizophrenia or bipolar disorder demonstrated that Staccato® loxapine (AZ-004) reduced agitation in patients, regardless of the level of agitation at baseline.  Improvement in agitation levels were observed as early as 10 minutes after dosing on ...

MOUNTAIN VIEW, Calif. , Feb. 11 /- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA ) announced today that the U.S. Food & Drug Administration has accepted the AZ-004 NDA for filing and has indicated a Prescription Drug User Fee Act (PDUFA) goal date of October 11, 2010 . ...

Alexza Pharmaceuticals, Inc. announced today that the U.S. Food & Drug Administration has accepted the AZ-004 NDA for filing and has indicated a Prescription Drug User Fee Act (PDUFA) goal date of October 11, 2010.

MOUNTAIN VIEW, Calif. , Feb. 10 /- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA ) announced today that it has established a collaboration with Biovail Laboratories International SRL, a subsidiary of Biovail Corporation (NYSE: BVF ), to develop and commercialize AZ-004 (Staccato® loxapine) in the U.S. and ...

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 ...