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FDA Advisory Committee Makes Recommendation to Approve Daiichi Sankyo's SAVAYSAT

October 31, 2014 8:28 am | News | Comments

Daiichi Sankyo announced that the FDA's Cardiovascular and Renal Drugs Advisory Committee voted 9 to 1 to recommend approval of once-daily SAVAYSAT 60 mg dosing regimen for the reduction in risk of stroke and systemic embolic events in patients with non-valvular atrial fibrillation.

FDA Approves Once-Daily XIGDUO™ XR Tablets for Adults with Type 2 Diabetes

October 30, 2014 8:04 am | News | Comments

AstraZeneca today announced that the FDA has approved once-daily XIGDUO™ XR (dapagliflozin and...

FDA Grants Accelerated Approval to Pfizer’s TRUMENBA®

October 29, 2014 3:22 pm | News | Comments

Pfizer announced that the FDA has granted accelerated approval of TRUMENBA ® (meningococcal...

US Health Care Unprepared for Ebola

October 29, 2014 2:00 pm | by JEFF DONN, Associated Press; GARANCE BURKE, Associated Press | News | Comments

The U.S. health care apparatus is so unprepared and short on resources to deal with the deadly...

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How Some Colored Contacts Could Permanently Damage Your Eyes

October 28, 2014 8:53 am | Videos | Comments

The U.S. government is working to seize all colored contacts not approved by the FDA.                            

New Warning for Dietary Supplement Users

October 23, 2014 10:46 am | Videos | Comments

Researchers at Harvard found that two-thirds of dietary supplements that have previously been recalled still contain banned ingredients. Also, smoking may get in the way of recovering alcoholics.         

Vaxart Accelerates Development of Ebola Tablet Vaccine

October 23, 2014 8:10 am | News | Comments

Vaxart, a privately held company developing vaccines that are administered by tablet rather than by injection, today announced that the company is accelerating its Ebola tablet vaccine program. Following a recent meeting with the FDA, Vaxart anticipates commencing human clinical trials in the first quarter of 2015.

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GlobalData Analyst: Harvoni Will Keep Gilead Atop Hepatitis C Virus Treatment Landscape

October 22, 2014 10:43 am | News | Comments

The recent FDA approval of Harvoni, Gilead Sciences’ once-daily, single-tablet regimen to treat chronic hepatitis C virus genotype 1 infection in adults, will enable the company to maintain its dominance in an increasingly competitive market, says an analyst with research and consulting firm GlobalData.

Study Finds Drugs Still in Recalled Supplements

October 22, 2014 8:58 am | by LINDSEY TANNER, AP Medical Writer | News | Comments

Dietary supplements containing potentially dangerous prescription drug ingredients may still be for sale even years after safety recalls, a study found. In supplements bought online, researchers detected hidden steroids, similar ingredients to Viagra and Prozac and a weight loss drug linked with heart attacks.

FDA Recommends Approval of KALYDECO®

October 22, 2014 8:51 am | News | Comments

Vertex announced that the FDA’s Pulmonary Allergy Drugs Advisory Committee voted 13-2 to recommend approval of KALYDECO® in people with cystic fibrosis ages 6 and older who have the R117H mutation in the cystic fibrosis transmembrane regulatory gene, which is the indication being reviewed by the FDA.

FDA Accepts NDA for Empagliflozin/Metformin Fixed-Dose Combination

October 21, 2014 9:01 am | News | Comments

The FDA has accepted the filing of a New Drug Application for empagliflozin plus immediate-release metformin hydrochloride fixed-dose combination, an investigational compound being studied for the treatment of adults with type 2 diabetes.  

FDA Recommends Approval of Novartis’ AIN457 (secukinumab) for Moderate-to-Severe Plaque Psoriasis

October 20, 2014 3:28 pm | News | Comments

Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the FDA voted 7 to 0 to support the approval of AIN457, a selective interleukin-17A inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

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Pharmaceutical Processing's October 2014 Issue

October 20, 2014 11:34 am | Digital Editions | Comments

The October issue of Pharmaceutical Processing describes Capsugel’s merger with Bend Research and Encap to create a comprehensive solid dosage form solutions group. The issue also features articles on supply chain trends including how to reduce risk, managing a clinical supply chain,  a look at the best printing and coding solutions, and the move to the fully connected enterprise. Other articles focus on particle size analysis, disposable chromatography technologies, and monitoring potency assays.

Halozyme Receives FDA Approval for Additional Manufacturing Facilities For Hylenex Recombinant

October 20, 2014 9:02 am | News | Comments

The FDA approved the use of the Cook Pharmica manufacturing facility in Bloomington, Indiana for the production of bulk rHuPH20, the active ingredient used in Hylenex, and the Patheon facility in Greenville, North Carolina, for production of finished Hylenex product.

Anti-Abuse Label Approved for Painkiller Embeda

October 17, 2014 8:36 pm | by The Associated Press | News | Comments

The U.S. Food and Drug Administration says it has approved new labeling for another opioid designed to limit painkiller abuse. The FDA said Friday that Pfizer Inc.'s Embeda can have labeling indicating that it has properties expected to reduce abuse of the drug when it is crushed and taken orally or snorted.

Chimerix Gets FDA OK to Test Drug for Ebola

October 17, 2014 11:39 am | News | Comments

Chimerix has received FDA clearance to proceed with a trial examining the safety and effectiveness of its brincidofovir tablets in patients who have the virus.               

FDA Panel Votes to Keep Boxed Warning on Chantix

October 16, 2014 4:36 pm | by The Associated Press | News | Comments

Federal health advisers say a bold-letter warning about suicide risks with Pfizer's Chantix should remain on the anti-smoking drug until it can reevaluated based on new, rigorous study information. Eleven advisers to the Food and Drug Administration voted to retain the so-called black box warning.

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HHS Advances Development of Third Ebola Vaccine

October 16, 2014 3:39 pm | News | Comments

The development of a vaccine to prevent Ebola virus disease will be accelerated with support from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR).      

FDA Approves Esbriet to Treat Idiopathic Pulmonary Fibrosis

October 16, 2014 8:41 am | News | Comments

Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and have difficulty participating in everyday physical activities.  

Hospira Announces Voluntary Nationwide Recall of Certain Lots of Several Lifecare Products

October 15, 2014 8:44 am | News | Comments

Hospira has announced the voluntary recall of certain lots of several products in its LifeCare™ line of flexible intravenous solutions due to the potential for leakage.              

FDA: Little Evidence to Drop Chantix Boxed Warning

October 14, 2014 11:50 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

Federal regulators say Pfizer has provided low-quality evidence to support its request to remove a bold-letter warning from its anti-smoking drug Chantix about suicidal behavior. The twice-a-day tablet has carried the FDA's strongest warning label, known as a black box, since 2009 following reports of suicidality, hostility and depression among some patients.

FDA Accepts Pfizer's Palbociclib New Drug Application for Priority Review

October 14, 2014 8:52 am | News | Comments

This NDA requests FDA approval of palbociclib, in combination with letrozole, as a first-line treatment for postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease.

FDA Approves VELCADE® for Injection for Previously Untreated Patients with Mantle Cell Lymphoma

October 9, 2014 1:48 pm | News | Comments

Millennium: The Takeda Oncology Company with its parent company, Takeda Pharmaceutical Company Limited, today announced that the FDA has approved VELCADE® for injection for use in previously untreated patients with mantle cell lymphoma. VELCADE is the first treatment in the United States to be approved for use in previously untreated patients with MCL.

FDA Grants Priority Review for Genentech’s Lucentis in Diabetic Retinopathy

October 8, 2014 3:35 pm | News | Comments

Genentech announced that the FDA has accepted to file the company's supplemental Biologics License Application and granted Priority Review of Lucentis® for the treatment of diabetic retinopathy, an eye disease that impacts nearly 7.7 million Americans. The FDA confirmed action date is February 6, 2015.

Bristol-Myers Squibb Withdraws NDA for Hepatitis C Treatment

October 7, 2014 8:43 am | News | Comments

Bristol-Myers Squibb has decided that it will not pursue FDA approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the United States and has therefore withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor.

Experimental Drug Provided to Dallas Ebola Patient

October 6, 2014 3:14 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

Officials at Texas Health Presbyterian Hospital said Monday that their patient, Thomas Eric Duncan, is in critical condition and being treated with brincidofovir, an oral medicine developed by Chimerix Inc.        

Sunesis Pharma Shares Sink

October 6, 2014 8:52 am | by The Associated Press | News | Comments

Shares of Sunesis Pharmaceuticals tanked Monday, wiping out all their gains for 2014 and then some, after the drug developer said its treatment for an aggressive form of blood cancer missed its main goal in late-stage testing.     

FDA Approves AbbVie's HUMIRA for Patients Ages Two and Older

October 6, 2014 8:20 am | News | Comments

AbbVie has announced that the FDA has approved the extension of the HUMIRA indication for moderately to severely active polyarticular juvenile idiopathic arthritis to reducing signs and symptoms in patients ages 2 and older. HUMIRA was approved in the United States in 2008 for polyarticular juvenile idiopathic arthritis in patients ages 4 and older.

Zogenix Submits Harder-to-Abuse Zohydro to FDA

October 1, 2014 3:11 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

Zogenix has submitted a Food and Drug Administration application for a new formulation of Zohydro that is designed to be more difficult to snort or inject — two common methods for abusing painkillers. Zogenix expects approval in the first quarter of 2015, which would allow the drugmaker to replace the older version of Zohydro in the second quarter.

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