Advertisement
FDA
Subscribe to FDA

The Lead

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,...

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-...

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...

View Sample

FREE Email Newsletter

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.                

Advertisement

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.

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.

Advertisement

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).          

Advertisement

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.    

NIH Finds Old Ricin, Other Forgotten Germs in Labs

September 8, 2014 8:23 am | by LAURAN NEERGAARD, AP Medical Writer | News | Comments

The National Institutes of Health said it has uncovered a nearly century-old container of ricin and a handful of other forgotten samples of dangerous pathogens as it combs its laboratories for improperly stored hazardous materials.   

Keryx Gets FDA Approval for New Kidney Disease Drug

September 5, 2014 12:06 pm | News | Comments

The FDA approved the company's ferric citrate drug to treat patients on dialysis with hyperphosphatemia, or elevated levels of phosphates, which can increase the risk of heart disease, bone density problems and death. Keryx estimates that between 350,000 and 375,000 U.S. dialysis patients take medication to control their phosphate levels, representing a total market of $1.2B.

FDA Removes Partial Clinical Hold on OncoMed's Ipafricept

September 5, 2014 8:57 am | News | Comments

OncoMed Pharmaceuticals announced that the FDA has removed the partial clinical hold on the company's ipafricept Phase 1 clinical trials. Enrollment and dosing of new patients is expected to resume within the next few weeks as the study sites' institutional review boards (IRBs) receive and approve the revised trial protocols.

U.S. Marshals Seize Drug Products from Flawless Beauty

September 5, 2014 8:24 am | News | Comments

Various unapproved and improperly labeled drug products that were marketed, sold and distributed via the Internet by Flawless Beauty LLC, of Asbury Park, New Jersey, have been seized by U.S. Marshals at the request of the U.S. Food and Drug Administration and the U.S. Attorney for the District of New Jersey.

FDA Accepts Actavis’ NDA Filing for Ceftazidime-Avibactam

September 5, 2014 8:18 am | News | Comments

Actavis has confirmed that the FDA has accepted for filing Actavis' application for ceftazidime-avibactam, its investigational antibiotic for the treatment of patients with Complicated Urinary Tract Infections (cUTI) and Complicated Intra-Abdominal Infections (cIAI).

FDA Approves Keytruda for Advanced Melanoma

September 4, 2014 3:49 pm | News | Comments

The U.S. Food and Drug Administration has granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.       

FDA: Little Evidence to Support Testosterone Drugs

September 3, 2014 3:30 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

The Food and Drug Administration says there is little evidence that testosterone-boosting drugs taken by millions of American men are beneficial, though the agency is also unconvinced by studies suggesting the hormone carries serious risks.  

Zoetis Gets Conditional OK on Pig Virus Vaccine

September 3, 2014 10:33 am | by The Associated Press | News | Comments

Zoetis has received conditional approval from federal regulators for a vaccine that helps fight a virus that has killed millions of piglets since it started showing up in the United States last year. The company said that its vaccine for the porcine epidemic diarrhea virus should be available to veterinarians and pig farmers this month.

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