US FDA

U.S. FDA grant Spark Therapeutics & Pfizer Breakthrough Therapy Designation for SPK-9001

  • Posted on: 22 July 2016
  • By: Shalini.Sharma

Spark Therapeutics and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to SPK-9001, the lead investigational candidate in the companies' SPK-FIX program, in development for the treatment of hemophilia B. SPK-9001, a novel bio-engineered adeno-associated virus (AAV) capsid expressing a codon-optimized, high-activity human factor IX variant, is being investigated in an ongoing Phase 1/2 trial as a potential one-time therapy.

Relievant Medsystems, Inc. Receives FDA 510(k) Clearance for INTRACEPT

  • Posted on: 22 July 2016
  • By: Shalini.Sharma

Relievant Medsystems, Inc., a privately held medical device company pioneering the therapy of nerve ablation within vertebral bodies for the treatment of chronic low back pain, announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for the INTRACEPT® Intraosseous Nerve Ablation System.

CytoDyn Submits Orphan Drug Application to FDA for Pretreatment With PRO 140

  • Posted on: 22 July 2016
  • By: Shalini.Sharma

CytoDyn Inc. announces that it has submitted to the U.S. Food And Drug Administration (FDA) an application for orphan drug designation for the use of PRO 140 (humanized monoclonal antibody to CCR5) in the pretreatment of HIV Type-1 (HIV-1) infection in treatment-naïve adults while they are waiting for drug resistance assay results to construct a subsequent Highly Active Antiretroviral Therapy (HAART) regimen.  The generation of these assay results typically takes approximately two weeks.

Advaxis’ AXAL Receives Fast Track Designation by the FDA

  • Posted on: 22 July 2016
  • By: Shalini.Sharma

Advaxis, Inc. announced that the U.S. Food and Drug Administration (FDA) has designated the Company’s lead immunotherapy candidate, axalimogene filolisbac (AXAL), as a Fast Track product for adjuvant therapy for high-risk locally advanced cervical cancer patients. The investigation of AXAL in this under-served population will be conducted in accordance with the Special Protocol Assessment (SPA) recently granted by the FDA.   

FDA Authorize Viracor-IBT Laboratories, Inc.’s Zika Virus RT-PCR Test for Emergency Use

  • Posted on: 22 July 2016
  • By: Shalini.Sharma

Viracor-IBT Laboratories, Inc., a wholly-owned subsidiary of Eurofins Scientific (EUFI.PA), announced that it received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Zika Virus Real-time RT-PCR assay.  

More Damning Evidence Against GSK and FDA on Rosiglitazone

Further evidence has come to light suggesting that GlaxoSmithKline knew about an increased cardiac risk with the diabetes drug rosiglitazone (Avandia) as early as 2001 but withheld the data and that certain officials at the FDA conspired with the company to minimize the impact of later safety results. The news comes on the same day that the FDA advisory panel starts its two-day hearing on the cardiovascular safety of the drug.

FDA Launches Campaign to Improve Infusion-Pump Safety

The US Food and Drug Administration (FDA) today unveiled an ambitious campaign to improve the safety of external infusion pumps, which have triggered 56,000 FDA adverse event reports linked to more than 500 deaths and 87 product recalls from 2005 through 2009, according to the agency.

The campaign mostly affects the makers of external infusion pumps, which may find FDA inspectors visiting their plants to ensure that safe manufacturing and testing processes are in place.

FDA warning to Propylthiouracil

April 21, 2010 — The US Food and Drug Administration (FDA) has added a boxed warning to the drug label for propylthiouracil about reports of severe liver injury and acute liver failure, in some cases fatal, that have been reported in both adult and pediatric patients who used this drug.

Notice of the warning was sent today in an alert from MedWatch, the FDA's safety information and adverse event reporting program.

Poniard Pharma suspends efforts to obtain regulatory approval for picoplatin in SCLC

 Poniard Pharmaceuticals, Inc., a biopharmaceutical company focused on innovative oncology therapies, announced a clinical and regulatory update on its lead product candidate, picoplatin. Following a detailed analysis of primary and updated data from the phase 3 SPEAR study of picoplatin in small cell lung cancer (SCLC) and an evaluation of the ongoing New Drug Application (NDA) process with the US Food and Drug Administration (FDA), the company has decided to suspend its efforts to obtain regulatory approval for picoplatin in SCLC at this time.

Pages