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Latest U.S. Food and Drug Administration Stories

2014-10-22 16:28:46

FLINT, Mich., Oct. 22, 2014 /PRNewswire/ -- U.S. Food and Drug Administration (FDA) announced October 10, 2014 that Gilead Sciences Harvoni(® )(ledipasvir/sofosbuvir) product was approved for the treatment of chronic hepatitis C, genotype 1 infection in adults. Harvoni(®) is the first oral combination therapy approved for the treatment of hepatitis C and is also the first treatment regimen that does not require administration with pegylated interferon or ribavirin....

2014-10-22 16:28:03

SILVER SPRING, Md., Oct. 22, 2014 /PRNewswire-USNewswire/ -- As fall arrives, so do drives in the country and drinking fresh-squeezed juices and cider. Unfortunately, serious outbreaks of foodborne illness, also called food poisoning, have been traced to drinking fruit and vegetable juices and cider that have not been processed to kill harmful bacteria. The U.S. Food and Drug Administration (FDA) reminds consumers to read the label carefully on juice or cider products they...

2014-10-22 08:32:29

-- Studies will accelerate IND-enabling development of VesiculoVax(TM) Ebola vaccine -- BALTIMORE, Oct. 22, 2014 /PRNewswire/ -- Profectus BioSciences, Inc. announced today that the company has received a contract from the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) aimed at accelerating the advancement of the company's candidate Ebola vaccine into human clinical studies. In previous preclinical studies conducted in...

2014-10-13 23:08:53

U.S. Food and Drug Administration selects DRT Strategies as the sole prime contractor for its five-year, Blanket Purchase Agreement to provide CDRH Information Management Support services. Arlington, Virgina (PRWEB) October 13, 2014 DRT Strategies, Inc. (DRT) (http://www.drtstrategies.com), a leading management and technology consulting firm to federal agencies, the U. S. Navy, and commercial technology and financial services clients, announced today that the U.S. Food and Drug...

2014-10-13 08:27:07

SARATOGA, Calif., Oct. 13, 2014 /PRNewswire/ -- VisionCare Ophthalmic Technologies, Inc. ("VisionCare"), a developer of advanced visual prosthetic devices for the treatment of age-related macular degeneration (AMD), today announced the U.S. Food and Drug Administration approved the Implantable Miniature Telescope (by Dr. Isaac Lipshitz) for use in patients living with bilateral end-stage age-related macular degeneration who are age 65 or older. The telescope implant is the only FDA...

2014-10-09 08:27:14

NASDAQ: NVCNTSX: NVC VANCOUVER, Oct. 9, 2014 /PRNewswire/ - Neovasc Inc. ("Neovasc" or the "Company") (NASDAQ: NVCN) (TSX: NVC) today announced that it has received conditional Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate the U.S. arm of its TIARA-I Early Feasibility Trial for the Company's Tiara(TM) transcatheter mitral valve. The TIARA-I Early Feasibility Trial is a multinational, multicenter trial being conducted to...

2014-10-09 04:20:56

PHILADELPHIA, October 9, 2014 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that it has received further guidance from the U.S. Food and Drug Administration (FDA) on the regulatory path for SHP 465 (triple-bead mixed amphetamine salts MAS), an investigational oral stimulant medication being evaluated as a potential treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) in adults. On April 25, 2014, in written correspondence, the FDA responded to...

2014-10-07 08:30:55

SAN DIEGO, Oct. 7, 2014 /PRNewswire/ -- DNAtrix, Inc., experts in oncolytic virus development, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for DNX-2401, a conditionally-replicative oncolytic adenovirus for malignant glioma. Glioma is the most common form of primary brain cancer, the treatment of which remains a significant unmet medical need. Under the designation, companies are provided with development and commercial...

2014-10-06 20:23:33

Conference Call Scheduled for Tuesday, October 7 at 8:00 AM Eastern Time RALEIGH, N.C., Oct. 6, 2014 /PRNewswire/ -- BioDelivery Sciences International, Inc. (BDSI) (NASDAQ: BDSI) will host an investor update conference call and webcast to discuss the launch of BUNAVAIL(TM) (buprenorphine and naloxone) buccal film (CIII) which has been approved by the U.S. Food and Drug Administration (FDA) for the maintenance treatment of opioid dependence. The conference call and webcast will...

2014-10-06 08:28:37

- Lead Product DALVANCE(TM) a Novel Antibiotic for Unmet Medical Need in Hospital and Outpatient Settings - DUBLIN, Ireland and CHICAGO, Oct. 6, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT), a leading global specialty pharmaceutical company, and Durata Therapeutics, Inc. (NASDAQ: DRTX), an innovative pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses, today announced that they...


Word of the Day
negawatt
  • A unit of saved energy.
Coined by Amory Lovins, chairman of the Rocky Mountain Institute as a contraction of negative watt on the model of similar compounds like megawatt.