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Latest Prescription Drug User Fee Act Stories

2014-09-17 08:31:00

HAYWARD, Calif., Sept. 17, 2014 /PRNewswire/ -- Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the RYTARY(TM) (IPX066) New Drug Application (NDA) from October 9, 2014, to January 9, 2015. The Company amended the chemical, manufacturing and control (CMC) section of the RYTARY NDA subsequent to...

2014-09-15 08:28:36

MONMOUTH JUNCTION, N.J., Sept. 15, 2014 /PRNewswire/ -- Vernalis plc (LSE: VER) and Tris Pharma, Inc. ("Tris") are pleased to announce that the U.S. Food and Drug Administration ("FDA") has confirmed that the New Drug Application ("NDA") for Tuzistra(TM) XR ("CCP-01") has been accepted for full review. This triggers a milestone payment from Vernalis to Tris. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date for conclusion of its review of 30 April 2015. Under...

2014-09-12 12:25:50

-- Company Expects to File IND to Support Clinical Trials in Mid-2015 -- ROCKVILLE, Md., Sept. 12, 2014 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a biotechnology company developing novel anti-infective biologic and drug programs targeting specific pathogens that cause serious infections and diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to the Company's proprietary SYN-005 monoclonal antibody (mAb)...

2014-09-10 12:28:10

The Emergence of Keytruda--the First PD-1 Inhibitor Approved in the U.S.--is a Significant Milestone in Oncology, According to Decision Resources Group BURLINGTON, Mass., Sept. 10, 2014 /PRNewswire/ -- The recent approval of Merck & Co.'s Keytruda by the U.S. Food and Drug Administration for the treatment of malignant melanoma is a significant milestone for Merck & Co. and for the oncology immunotherapy drug market. Decision Resources Group anticipates the launch of Keytruda as the...

2014-09-06 08:20:30

NORTHBROOK, Ill., Sept. 6, 2014 /PRNewswire/ -- Astellas today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis), which are life-threatening fungal infections predominantly occurring in immunocompromised patients. In accordance with the FDA Prescription Drug User Fee Act (PDUFA), the FDA designated the date...

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(®)...

2014-08-06 12:29:28

Nephrologists Seem More Confident That an Iron-Based Phosphate Binder Will Impact the Use of IV Iron vs. the Use of ESAs, According to Findings from Decision Resources Group BURLINGTON, Mass., Aug. 6, 2014 /PRNewswire/ -- Decision Resources Group finds that there is a high need for new phosphate binders to treat hyperphosphatemia among surveyed U.S. nephrologists (n=102). Phosphate binders with fewer pills, better efficacy in reducing serum phosphorous and improved tolerability are rated as...

2014-08-05 12:06:50

Boston University Medical Center Study compared warning and withdrawal rates for drugs released before and after the drug industry increased funding to the FDA to expedite drug approvals What's safer: a newly approved drug or one that has been on the market much longer? Newer drugs have a one in three chance of acquiring a black box warning or being withdrawn for safety reasons within 25 years of their approval, according to a new study by researchers from Cambridge Health Alliance...

2014-08-05 08:33:24

QUÉBEC CITY, Aug. 5, 2014 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced a strategic co-promotion services agreement with ASCEND Therapeutics(®) US, LLC, ("ASCEND"). Under the terms of the agreement, expected to start in the fourth quarter of 2014, Aeterna Zentaris will use its newly established commercial structure to market, in specific U.S. territories, ASCEND's EstroGel(® )a non-patch transdermal U.S. Food & Drug...

2014-07-29 08:32:31

HAYWARD, Calif., July 29, 2014 /PRNewswire/ -- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) performed a general GMP inspection and a Pre-Approval Inspection (PAI) for RYTARY(TM )at the Company's Taiwan manufacturing facility from July 21 to July 26, 2014. At the conclusion of the inspection, the FDA issued a Form 483 with ten inspectional observations. The Taiwan facility was approved for product manufacturing by the FDA in...


Word of the Day
cruet
  • A vial or small glass bottle, especially one for holding vinegar, oil, etc.; a caster for liquids.
This word is Middle English in origin, and ultimately comes from the Old French, diminutive of 'crue,' flask.
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