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Latest U.S. Food and Drug Administration Stories

2014-08-28 08:28:27

Represents First BLA Submission for a PCSK9 Inhibitor THOUSAND OAKS, Calif., Aug. 28, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for evolocumab seeking approval for the treatment of high cholesterol. Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to...

2014-08-27 08:28:22

THOUSAND OAKS, Calif., Aug. 27, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the U.S. Food and Drug Administration (FDA) has granted priority review designation for ivabradine for the treatment of chronic heart failure (HF). Ivabradine is an oral drug that inhibits the I(f) current ("funny" current) in the sinoatrial node, the body's cardiac pacemaker.(1) Ivabradine works to slow the heart rate without negative effects on myocardial contractility or ventricular...

2014-08-26 08:31:41

New JARDIANCE Simple Savings program currently offered in doctors' offices and online RIDGEFIELD, Conn. and INDIANAPOLIS, Aug. 26, 2014 /PRNewswire/ -- Jardiance(®) (empagliflozin) tablets are now available by prescription in pharmacies across the United States, including Walgreens, Rite Aid, Kroger and many other leading chain and independent retailers, according to Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY). The U.S. Food and Drug Administration...

2014-08-25 08:27:12

Initial Closing is for $10 Million FREDERICK, Md., Aug. 25, 2014 /PRNewswire/ -- Vaccinogen, Inc., (OTC.QB: VGEN) a cancer immunotherapy development company, announced today that it completed the initial closing of a private placement of $80 million of units and common stock. Vaccinogen received gross proceeds of $10 million in this first closing. http://photos.prnewswire.com/prnvar/20140825/139089 Vaccinogen is preparing to start ACTIVE, a confirmatory Phase IIIb pivotal...

2014-08-19 12:28:32

For U.S. Media Only RIDGEFIELD, Conn., Aug. 19, 2014 /PRNewswire/ -- Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for the fixed-dose combination (FDC) of tiotropium and olodaterol delivered via the Respimat(®) inhaler for the proposed indication of long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including...

2014-08-19 08:29:50

VAL-083 Phase I/II VAL-083 clinical trial advances to 50mg/m(2) cohort VANCOUVER, British Columbia and MENLO PARK, Calif., Aug. 19, 2014 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (OTCQB: DMPI) ("DelMar" "the company") announced today a protocol amendment to allow for expanded dosing in its VAL-083 clinical trial had been filed with the U.S. Food and Drug Administration (FDA) and that a new cohort of a new 50mg/m(2) has been opened at three clinical trial sites in the United...

2014-08-13 16:26:02

THOUSAND OAKS, Calif., Aug. 13, 2014 /PRNewswire/ -- Amgen (NASDAQ:AMGN) initiated a voluntary recall on June 26, 2014 for nine packaged lots of Aranesp(®) (darbepoetin alfa) (500 mcg) prefilled syringes from non-U.S. distributors, wholesalers and a number of hospital pharmacies due to the potential presence of cellulose and/or polyester particles observed in a small number of syringes during a routine quality examination. Lots 1042847, 1044141A, 1044141C, 1044141D, 1046891A, 1046891B,...

2014-08-11 16:27:34

REDWOOD CITY, Calif., Aug. 11, 2014 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today reported financial results for the three and six months ended June 30, 2014. On July 25, 2014, AcelRx announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Company's new...

2014-08-07 04:21:40

SEATTLE, Aug. 7, 2014 /PRNewswire/ --CTI BioPharma Corp. (CTI or the Company) (NASDAQ and MTA: CTIC) announced today that pacritinib has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of intermediate and high risk myelofibrosis, including but not limited to patients with disease related thrombocytopenia, patients experiencing treatment emergent thrombocytopenia on other JAK2 therapy or patients who are intolerant to or whose...

2014-08-06 16:28:59

-- Transformational H1 2014 includes presentation of Phase 3 ASCEND data, NDA resubmission and target PDUFA date of Nov. 23 for pirfenidone in U.S. - BRISBANE, Calif., Aug. 6, 2014 /PRNewswire/ -- InterMune, Inc. (NASDAQ: ITMN) today announced results from operations for the second quarter ended June 30, 2014. The company also highlighted recent clinical development and business highlights, and updated its forward-looking financial guidance for 2014. InterMune reported Esbriet(®)...


Word of the Day
cock-a-hoop
  • Exultant; jubilant; triumphant; on the high horse.
  • Tipsy; slightly intoxicated.
This word may come from the phrase 'to set cock on hoop,' or 'to drink festively.' Its origin otherwise is unclear. A theory, according to the Word Detective, is that it's a 'transliteration of the French phrase 'coq a huppe,' meaning a rooster displaying its crest ('huppe') in a pose of proud defiance.' Therefore, 'cock-a-hoop' would 'liken a drunken man to a boastful and aggressive rooster.'
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