Takeda responds to the FDA advisory committee recommendation
... The breadth and depth of ACTOS data encompassing more than 16,000 patients over the past 10 yearsis consistent: Short- and long-term studies, both prospective and observational, s...Home health care devices focus of FDA Conference at UH
... The U.S. Food and Drug Administration and the University of Houston are addressing this issue at an FDA conference Home Health Care Technology: Promoting the Safe Migration of Medical Devices into the Home cosponsored by UH Sept. 17-18 at the Hilton UH Hotel and Conference...Abilify sNDA for pediatric patients with schizophrenia accepted for priority FDA review
(TOKYO, JAPAN and PRINCETON, NJ, JUNE 5, 2007) Otsuka Pharmaceutical Co, Ltd., and Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority (six month review target) review the supplemental New Drug Application (sNDA) of the atypical antipsychotic ABILIFY (aripiprazole) for the treatment of pediatric patients (13-17 year...FDA grants priority review of Remicade® for children with Crohn's disease
HORSHAM, Pa. - Centocor, Inc. announced today that the supplemental Biologics License Application (sBLA) for REMICADE (R) (infliximab) for the treatment of pediatric Crohn's disease has been accepted and designated for Priority Review by the U.S. Food and Drug Administration (FDA). Centocor is seeking approval for the treatment of moderately to severely active pediatric Crohn's disease in patien...Bradley Hospital responds to FDA report on ADHD drugs
In response to the recent FDA report linking ADHD drugs such as Ritalin to the deaths of 25 people, Bradley Hospital, the nation's first psychiatric hospital for children, and pioneer in the use of Benzedrine (a close relative of Ritalin) to treat attention disorders in children, has issued the following statement: ... ..."Like all child mental health professionals, we at Bradley Hospital enthusi...FDA approves ZYFLO CR extended-release tablets for chronic treatment of asthma
... ZYFLO CR and ZYFLO (zileuton tablets) are the only FDA-approved leukotriene synthesis inhibitors for the prophylaxis and chronic treat...Researchers find deadly prescription drug effects 6 years before FDA
...... ... ...... CHICAGO -- Northwestern Universitys Charles Bennett, M.D., is a super sleuth of potentially deadly prescription drug reactions. He leads a national SWAT team of doctors called RADA...U of M faculty honored by US FDA for contributions to national food safety and defense
Three University of Minnesota faculty members will be awarded special citations from the U.S. Food and Drug Administration (FDA) for their contributions to maintaining and promoting national food safety and defense. The awards will be presented at the 47th Annual FDA Honor Awards Ceremony, "Transforming for the Next Century," Friday, May 11 in Gaithersburg, Md. ... Frank Busta, Ph.D., director...FDA approves Dey, L.P.'s Perforomist inhalation solution for maintenance treatment of COPD
... Formoterol is a rapid and long-lasting beta2 agonist that has been previously approved in the U.S. as a dry powder formulation, and the molecule has twenty years of worldwide use. Perforomist Inhalation Solution is t...National experts and nonprofit organizations call to end FDA user fees and to improve drug safety
... <p...FDA's modern risk-based approach opens dialogue with industry
WHAT: AAPS and ISPE are pleased to present the FDA's Pharmaceutical Quality Initiatives: Implementation of a Modern Risk-Based Approach, an interactive workshop that will provide updates on the progress of the FDA's pharmaceutical quality initiatives since the 2004 report "Pharmaceutical GMPs for the 21st Century," and will serve as an open forum for industry, other stakeholders, and the public...SCAI president testifies before FDA on safety of drug-eluting stents
... As president of SCAI, Dr. Dehmer spoke on behalf of the professional organization representing the vas...VCR -- FDA approves home discharge for US patients
... ... "Removing this requirement makes participation in the US Feasibility Trial more attractive to patients because they are able to return to their...Breast cancer drug receives FDA approval
LEXINGTON, Ky. (Nov. 17, 2006) − A new use for the breast cancer drug Herceptin was approved by the FDA yesterday, a move that means more treatment options for the 25 percent of breast cancer patients with early-stage HER-2 positive breast cancer. ... Dr. Edward Romond, a cancer specialist and researcher at UK HealthCare's Markey Cancer Center, was instrumental in researching and analyzing...NIH scientists honored for FDA-approved cervical cancer vaccine breakthrough
The Mount Sinai Medical Center and The Samuel Waxman Foundation will honor Douglas Lowy, M.D., Laboratory Chief and Principal Investigator, Laboratory of Cellular Oncology, Division of Basic Sciences, National Cancer Institute, National Institutes of Health (NIH) and John Schiller, Ph.D., Deputy Chief and Principal Investigator, Laboratory of Cellular Oncology, Division of Basic Sciences, Nation...FDA approves prescription Zaditor for over-the-counter relief from itchy eyes
... While most OTC products provide only 3-4...EMEA and FDA extend drug-label based on results of the EORTC 24971 trial
In its September meeting 2006, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) gave a positive opinion to include the use of docetaxel in combination with the current standard treatment - cisplatin and 5 fluorouracil for the induction treatment of patients with inoperable locally advanced squamous cell carcinoma of the head and neck. On October...FDA approves Vectibix to treat patients with metastatic colorectal cancer
... The FDA approval of Vectibix was based on a progression-free survival endpoint. Ve...March of Dimes: Drug to prevent preterm birth needs prompt FDA approval
... ... "Studies of progesterone injections offer promise that the risk of recurrent preterm births will be reduced in a select group of women who already had a baby...FDA safety alerts for automated external defibrillators occur frequently
... Sudden cardiac death is a leading cause of death in the United States, accounting for nearly 330,000 deaths annually. Successful resuscitation of persons with cardiac arrest depends on prompt emergency care, with early defibrillation a key component to imp...FDA changes to accelerate patient recruitment
Ventracor Limited (ASX:VCR) incoming Chief Executive Officer Peter Crosby today said Ventracor had received approval from the US Food & Drug Administration (FDA) to immediately change the protocol for its US feasibility study to help complete recruitment.... ... "The FDA's approval of discharge to a non-acut...REVLIMID(R) granted approval by FDA for treatment of multiple myeloma
Summit, N.J., June 29 /PRNewswire-FirstCall/ -- Celgene Corporation (Nasdaq: CELG) announced that the U.S. Food and Drug Administration (FDA) ...has granted approval for its Supplemental New Drug Application (sNDA) for an additional indication for REVLIMID (lenalidomide), for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one pr...FDA should approve emergency contraceptive Plan B quickly to demonstrate its independence
Andrew von Eschenbach, acting US Food and Drug Administration (FDA) commissioner, should move quickly to approve emergency contraceptive Plan B to show he has the independence needed to head the organisation, states an editorial in this week's issue of The Lancet....von Eschenbach, former Director of the US National Cancer Institute (NCI), is President George W Bush's choice to lead the FDA. The...Study assesses relationship between conflicts of interest and voting patterns at FDA meetings
Disclosures of conflicts of interest at Food and Drug Administration (FDA) drug advisory committee meetings are common, often of considerable financial value, and rarely result in the recusal of advisory committee members, but excluding those with conflicts would not have altered the overall vote outcome at any meeting, according to a study published in the April 26 issue of JAMA....... The Cente...Shire's DAYTRANA(TM) transdermal patch approved by FDA for treatment of ADHD
Philadelphia, PA, US and Basingstoke, UK -- Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that the U.S. Food and Drug Administration (FDA) approved DAYTRANA (methylphenidate transdermal system), the first and only non-oral medication for the treatment of attention deficit hyperactivity disorder (ADHD). DAYTRANA, a once daily transdermal patch formulation of methylphenidate, will...AACR supports the nomination of Andrew von Eschenbach as the commissioner of the FDA
PHILADELPHIA The American Association for Cancer Research, the world's oldest and largest...organization dedicated to cancer research, enthusiastically supports the nomination of Andrew von Eschenbach as new commissioner of the U.S. Food and Drug Administration....... "Dr. von Eschenbach brings enormous medical and administrative expertise and experience to this post," said Margaret Foti, Ph.D.,...Experts to address use of patient-reported outcomes in clinical trials at joint Mayo-FDA forum
Dozens of medical research experts will assemble Feb. 23-25, 2006, in Chantilly, Va., to discuss how patient-reported outcomes (PROs) should be developed, validated, interpreted and used in clinical trials. This symposium, jointly sponsored by Mayo Clinic and the U.S. Food and Drug Administration (FDA), is a forum for discussion and feedback regarding the soon-to-be-released FDA draft guidance f...AACR supports new FDA clinical research guidelines
The American Association for Cancer Research, the world's oldest and largest organization dedicated to cancer research, enthusiastically supports the new guidelines announced today by the U.S. Food and Drug Administration, whose primary goal is to streamline the earliest phases of clinical research for new medical treatments....... As described, the new guidelines are in keeping with FDA's Critic...Mayo Clinic co-sponsoring FDA forum on patient-reported outcomes
ROCHESTER, Minn. -- Mayo Clinic and the U.S. Food and Drug Administration (FDA) are co-sponsoring a unique symposium Feb. 23-25, 2006, in Chantilly, Va., to discuss and respond to draft FDA guidance on how to best incorporate Patient-Reported Outcomes (PROs) into clinical trial development and evaluation. ...... "Patient-reported outcomes, which include topics such as symptom burden and quality o...Biosense Webster announces FDA clearance
Diamond Bar, CA October 12, 2005 Biosense Webster, Inc. today announced that the company has received clearance by the U.S. Food and Drug Administration (FDA) for devices that aid electroanatomical mapping. The CARTO RMT Catheter with the QWIKPATCH External Reference Patch products were all designed to integrate with the Niobe Magnetic Navigation System designed by Stereotaxis, Inc. The cleara...FDA approves room temperature storage of ZLB Behring's Helixate FS
King of Prussia, PA--(BUSINESS WIRE)--Oct. 7, 2005 -- ZLB Behring announced today that Helixate FS has received approval to be stored at room temperature (up to 25 degrees C, 77 degrees F) for three months. The new storage guidelines for the treatment will provide users with greater flexibility and simplify storage options. ... ...The United States Food and Drug Administration (FDA) approved t...GSK accused of misleading FDA on safety of asthma drug
GlaxoSmithKline (GSK) is accused of manipulating the trial data it submitted...to the US Food and Drug Administration (FDA) on its asthma drug salmeterol in a correspondence letter in this week's issue of The Lancet....... In 1996, due to reports of negative side-effects with the use of GSK's newly...approved salmeterol, and asthma-related deaths in patients taking the same...class of drugs, the...THOUSAND OAKS, Calif., (Sept. 15, 2005) Amgen (Nasdaq: AMGN), the world's largest biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) approved an update to the Neulasta (pegfilgrastim) prescribing information to include data from a landmark Phase 3 study demonstrating the white blood cell booster helps protect patients with most types of cancer undergoing mode...GlaxoSmithKline announces FDA approval of Fluarix
PHILADELPHIA, PA, August 31, 2005 In a major step toward increasing flu vaccine supply in the United States, GlaxoSmithKline [NYSE:GSK] announced today that the U.S. Food and Drug Administration has approved its influenza vaccine, FLUARIX™ [Influenza Virus Vaccine] for distribution in time for the 2005/2006 influenza season....... The introduction of FLUARIX, indicated for adults 18 and ol...FDA expands indication for ADDERALL XR (CII) confirming safety and efficacy in adolescents
Philadelphia, US July 22, 2005 Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that the US Food and Drug Administration (FDA) has approved ADDERALL XR (mixed salts of a single-entity amphetamine product) as a once-daily treatment for adolescents aged 13 to 17 with attention deficit hyperactivity disorder (ADHD). Since October 2001, ADDERALL XR has been appro...FDA approved ROZEREM (ramelteon)
LINCOLNSHIRE, Ill., July 22 Takeda Pharmaceuticals North America, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ROZEREM (ramelteon) 8-mg tablets for the treatment of insomnia characterized by difficulty with sleep onset. The FDA approval allows physicians to prescribe ROZEREM for long-term use in adults.... ROZEREM is the...FDA approves new indication for Topamax as initial monotherapy for adults and children with epilepsy
TITUSVILLE, NJ, June 30, 2005 -- The U.S. Food and Drug Administration (FDA) yesterday approved a new use for TOPAMAX (topiramate) Tablets and TOPAMAX (topiramate capsules) Sprinkle Capsules as initial monotherapy in patients 10 years of age and older with partial-onset or primary generalized tonic-clonic seizures....... Effectiveness was demonstrated in a controlled trial in patients with epilep...FDA approves first blood test to predict risk for stroke
HOUSTON, June 17, 2005 The U.S. Food and Drug Administration (FDA) approved today the first blood test designed to help predict a patient's risk for ischemic stroke, the most common type of stroke and one of the nation's leading causes of long-term disability affecting approximately 700,000 people per year.... ..."This test provides a new tool to help us identify at-risk patients earlier, so we...FDA approves Boostrix a new US vaccine for adolescents against pertussis
PHILADELPHIA, PA, May 3, 2005 GlaxoSmithKline (NYSE: GSK) today announced that its booster vaccine, Boostrix [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap)] received approval from the United States (U.S.) Food and Drug Administration (FDA). Boostrix is indicated to be given as a single dose to individuals aged 10 to 18 years thereby adding a pertussi...Orqis Medical receives unconditional FDA approval for pivotal trial of percutaneous CHF therapy
Lake Forest, Calif. April 26, 2005 Orqis Medical Corporation, developer of the novel and proprietary catheter-based Cancion cardiac recovery system (CRS ) to treat congestive heart failure (CHF), today announced U.S. Food and Drug Administration (FDA) unconditional approval for researchers to treat up to 200 CHF patients at 40 centers participating in the company's MOMENTUM pivotal clinical tri...