Advertisement
FDA
Subscribe to FDA

The Lead

FDA Approves NeuroGenetic Pharmaceuticals Application to Begin Clinical Trials for Its Alzheimer’s Disease Compound

September 29, 2014 12:06 pm | News | Comments

The U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application from NeuroGenetic Pharmaceuticals, Inc. (NGP) to begin clinical trials on its NGP 555 compound to treat and prevent Alzheimer’s disease (AD).

FDA Approves Revised Indication for Allergan's OZURDEX®

September 29, 2014 10:06 am | News | Comments

Allergan announced today that the U.S. Food and Drug Administration (FDA) has approved OZURDEX...

Alimera, pSivida say FDA Clears Eye Implant

September 26, 2014 5:45 pm | by The Associated Press | News | Comments

Alimera Sciences and pSivida said Friday the FDA approved their eye disease implant Iluvien....

AbbVie Gets Approval For Humira

September 26, 2014 10:48 am | News | Comments

The FDA cleared Humira as a treatment for moderate to severe Crohn's disease in children ages...

View Sample

FREE Email Newsletter

Pacira Pharmaceuticals Shares Drop As FDA Warns On Misleading Ads

September 25, 2014 9:34 am | by Associated Press | News | Comments

Pacira Pharmaceuticals Inc. said Thursday that it received a warning letter from regulators about marketing for an injectable drug that numbs post-surgical pain that the letter says is misleading.                                        

Anti-Addiction Groups Call for New FDA Chief

September 24, 2014 3:07 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

In a letter released Wednesday, more than a dozen groups ask the Obama administration's top health official to replace FDA Commissioner Dr. Margaret Hamburg, who has led the agency since 2009. The FDA has been under fire from public health advocates, politicians and law enforcement officials since last October, when it approved a powerful new painkiller called Zohydro against the recommendation of its own medical advisers.

New FDA Label Bolsters Safety Case for Chantix

September 24, 2014 11:43 am | News | Comments

New government-approved labeling on Pfizer's drug Chantix suggests that the anti-smoking medication may not carry the risks of suicidal behavior that first earned it the government's strongest warning more than five years ago.    

Advertisement

FDA Warns Doctors to Beware Fake Drug Distributors

September 23, 2014 3:21 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

U.S. health regulators are trying to help doctors spot counterfeit and unapproved drugs by raising awareness of illegal operations that peddle bogus drugs to health professionals. Beginning Tuesday the FDA will push back with its own educational campaign, faxing flyers to physicians across the country on how to recognize bogus offers and counterfeit drugs.

FDA Approves Fast Track Designation for Galmed Pharmaceuticals’ Aramchol

September 23, 2014 11:51 am | News | Comments

Galmed Pharmaceuticals announced that the U.S. Food and Drug Administration approved its request for Fast Track Designation of its product candidate, aramchol, for the treatment of Non-Alcoholic Steato-Hepatitis, or NASH.     

MedImmune Receives FDA Fast Track Designation for Development of MEDI3902 for Prevention of Nosocomial Pneumonia

September 23, 2014 8:22 am | News | Comments

AstraZeneca announced today that its global biologics research and development arm, MedImmune, has received fast track designation from the FDA for its investigational monoclonal antibody (mAb) MEDI3902 for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa (P. aeruginosa), a highly drug-resistant bacterial pathogen.

Amgen Submits BLA for Investigational BiTE Immunotherapy Blinatumomab

September 22, 2014 2:20 pm | News | Comments

The BLA is for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow. BiTE antibody constructs represent an innovative immunotherapy approach that helps the body's immune system target cancer cells.

FDA Revises Food Safety Rules Due Next Year

September 22, 2014 8:16 am | by MARY CLARE JALONICK, Associated Press | News | Comments

The Food and Drug Administration on Friday revised sweeping food safety rules proposed last year after farmers complained that the regulations could hurt business. The new proposals would relax water quality standards and allow farmers to harvest crops sooner after using raw manure as fertilizer.

Advertisement

FDA Approves Eli Lilly's Injectable Diabetes Drug

September 18, 2014 4:46 pm | by The Associated Press | News | Comments

The Food and Drug Administration has approved a new injectable diabetes drug from Eli Lilly and Co. for adults with the most common form of the disease. The agency on Thursday cleared the drug, Trulicity, as a weekly injection to improve blood sugar control in patients with type 2 diabetes.

Better Way to Diagnose Kidney Stones

September 18, 2014 9:02 am | Videos | Comments

A study in the New England Journal of Medicine found that the less expensive and radiation-free ultrasounds can detect kidney stones as well as the more expensive CT scans. Also, the FDA is investigating the increase in testosterone therapy by older men.

FDA OKs Faster-Acting Label for Stendra

September 18, 2014 8:37 am | by The Associated Press | News | Comments

Federal regulators have approved a new label for Vivus' impotence drug, stating that it becomes effective in half the time that the previous label had stated.                

Experts Want Restrictions on Testosterone Drug Use

September 17, 2014 6:44 pm | by Matthew Perrone - AP Health Writer - Associated Press | News | Comments

Federal health experts said Wednesday there is little evidence that testosterone-boosting drugs are effective for treating common signs of aging in men and that their use should be narrowed to exclude millions of Americans currently taking them. The panel of Food and Drug Administration advisers...

Baxter Recalls One Lot of Potassium Chloride Injection

September 17, 2014 3:00 pm | News | Comments

Baxter International Inc. announced today it is voluntarily recalling one lot of Potassium Chloride Injection 10mEq per 100mL, product code 2B0826 to the hospital/pharmacy/nurse level. The recall is being initiated due to a labeling error on the shipping cartons in a single lot, which was identified by three customers.

Advertisement

FDA Clears Constipation Drug Movantik

September 16, 2014 3:16 pm | News | Comments

Movantik, or naloxegol, is approved for adults who have chronic pain that is not caused by cancer. British drugmaker AstraZeneca PLC will market the drug, and it has also filed for regulatory approval in the European Union and Canada.   

EYLEA Injection Receives FDA Breakthrough Therapy Designation

September 16, 2014 9:03 am | News | Comments

Regeneron Pharmaceuticals today announced that the FDA has granted EYLEA (aflibercept) Injection Breakthrough Therapy designation for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME).      

Skin Shocks Used at Massachusetts School Draw FDA Scrutiny

September 15, 2014 8:44 am | by JENNIFER C. KERR, Associated Press; LAURAN NEERGAARD, Associated Press | News | Comments

The Food and Drug Administration is considering whether to ban devices used by the Judge Rotenberg Educational Center in Canton, Massachusetts, the only place in the country known to use skin shocks as aversive conditioning for aggressive patients.

FDA Approves Baxter’s HYQVIA for Treatment of Adults with Primary Immunodeficiency

September 15, 2014 8:31 am | News | Comments

Baxter International and Halozyme Therapeutics announced that the FDA approved Baxter’s subcutaneous treatment for adult patients with primary immunodeficiency (PI), HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase].

FDA Accepts Tuzistra XR NDA for Full Review

September 15, 2014 8:12 am | News | Comments

Vernalis and Tris Pharma announced that the FDA has confirmed that the New Drug Application for Tuzistra XR has been accepted for full review. This triggers a milestone payment from Vernalis to Tris.        

FDA Backs Novo Nordisk Injection for Obesity

September 11, 2014 5:47 pm | by The Associated Press | News | Comments

Federal health experts say a diabetes drug from Novo Nordisk should be approved for a new use in treating obesity. The panel of Food and Drug Administration advisers voted 14-1 that the injectable drug's benefits outweigh it risks for patients who are obese or dangerously overweight.

Silicon Valley Struggles to Speak FDA's Language

September 11, 2014 10:26 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

From Apple's new smartwatch that tracks heartbeats to contact lenses that measure blood sugar — Silicon Valley is pouring billions into gadgets and apps designed to transform health care. But the tech giants that have famously disrupted so many industries are now facing their own unexpected disruption: regulation.

FDA Approves New Indication for the Use of XTANDI Capsules

September 11, 2014 8:29 am | News | Comments

Astellas Pharma and Medivation announced today that the FDA approved a new indication for the use of XTANDI (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer (CRPC).          

FDA Approves Weight-Loss Drug Contrave

September 11, 2014 8:13 am | News | Comments

The drug is approved for use by people who have a body mass index of 30 or higher, which is the level at which people are considered to be obese. It is also approved for use by people with a BMI of 27 or higher who also have a weight-related medical condition such as diabetes.

FDA Advisory Committee Recommends Against Approval of Actavis' Hypertension Treatment

September 10, 2014 8:20 am | News | Comments

Actavis has confirmed that the FDA's Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted to recommend against approval of Actavis' New Drug Application (NDA) for the fixed-dose combination of nebivolol and valsartan for the treatment of hypertension.

FDA Approves Use of Menactra Vaccine for Booster Immunization Against Potentially Deadly Disease

September 8, 2014 2:55 pm | News | Comments

Sanofi Pasteur, the vaccines division of Sanofi, announced that the FDA has approved the use of Menactra [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine] for booster vaccination against meningococcal disease in persons 15 years through 55 years of age.

FDA Approves Two New Indications for Epaned

September 8, 2014 9:54 am | News | Comments

Silvergate Pharmaceuticals today announced that the FDA approved Epaned (enalapril maleate Powder for Oral Solution) for the treatment of symptomatic heart failure and the treatment of asymptomatic left ventricular dysfunctio.    

X
You may login with either your assigned username or your e-mail address.
The password field is case sensitive.
Loading