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Latest U.S. Food and Drug Administration Stories

2014-10-30 08:35:33

SAN DIEGO, Oct. 30, 2014 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its Vesicular Monoamine Transporter 2 inhibitor, NBI-98854, in tardive dyskinesia. A breakthrough therapy designation is granted for a drug that is intended to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may...

2014-10-30 08:35:10

-- Unique Billing Code Allows Separate Payment for Omidria -- SEATTLE, Oct. 30, 2014 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) announced today that it has received transitional pass-through status for its lead product Omidria((TM)) (phenylephrine and ketorolac injection) 1%/0.3% from the Center for Medicare & Medicaid Services (CMS), the federal agency that administers the Medicare program. Approved earlier this year by the U.S. Food and Drug Administration (FDA) for use...

2014-10-29 16:30:03

ATLANTA, Oct. 29, 2014 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) announced today the approval of Pfizer's Trumenba, the first vaccine in the United States to prevent serogroup B meningococcal disease in individuals ages 10 to 25. Before today, vaccines licensed in the U.S. protected against four major strains of the disease: A, C, W and Y. They did not prevent serogroup B meningococcal disease, which accounts for one-third of U.S. cases. The National Meningitis...

2014-10-27 23:11:49

The McGartland Law Firm announced today that it is now accepting cases involving patients who were injured as a result of defective hip implants, specifically either the Stryker Rejuvenate or ABG II hip implants manufactured by Stryker Orthopedics. TULSA, Oklahoma (PRWEB) October 27, 2014 The McGartland Law Firm announced today that it is now accepting cases involving patients who alleged that they were injured as a result of either the Stryker Rejuvenate or ABG II hip implants that were...

2014-10-27 16:28:51

- Henrico County Sheriff's Office to Receive First Donation - RICHMOND, Va., Oct. 27, 2014 /PRNewswire/ -- Kaleo, a privately-held pharmaceutical company headquartered in Richmond, Virginia, today announced a new donation program that will allow qualifying local law enforcement agencies to receive EVZIO(TM) naloxone auto-injectors without charge as part of the kaleo Cares program. EVZIO, approved by the U.S. Food and Drug Administration (FDA) on April 3, 2014, is an opioid antagonist...

2014-10-27 08:29:30

CUPERTINO, Calif., Oct. 27, 2014 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) reported today that Pfizer Inc. (NYSE: PFE) announced today that it has notified Pain Therapeutics, Inc. (Nasdaq: PTIE) that Pfizer has decided to discontinue its agreement to develop and commercialize REMOXY(®) (oxycodone) Extended-Release Capsules CII, an investigational extended-release oral formulation of oxycodone. Pfizer will return all rights, including responsibility for regulatory...

2014-10-24 20:22:05

HOUSTON, Oct. 24, 2014 /PRNewswire/ -- Burzynski Research Institute, Inc. (BRI) announced today that the U.S. Food and Drug Administration (FDA) has given the company permission to conduct an open-label study of Antineoplastons A10 and AS2-1 in patients > 3 months of age with a diffuse intrinsic brainstem glioma (DIPG). Study subjects will be placed in one of five treatment groups based on their age and whether or not they have received prior treatment for DIPG. The primary study...

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...


Word of the Day
maffling
  • To stammer.
  • Present participle of maffle, to stammer.
  • A simpleton.
The word 'maffle' may come from a Dutch word meaning 'to move the jaws' or a French word meaning 'having large cheeks'.