Abbott (NYSE: ABT) today announced it has received U.S. Food and Drug Administration (FDA) approval for the RX Herculink Elite® Renal Stent System for the treatment of renal artery stenosis (narrowing of the main arteries supplying blood to the kidneys) in patients with uncontrolled hypertension...
Relievant Medsystems, Inc. announced the company has received Food and Drug Administration approval of an Investigational Device Exemption (IDE) to begin their SMART pivotal trial to evaluate the safety and effectiveness of the Intracept® System for treatment of chronic low back pain. The SMART...
Intelliject, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the company's New Drug Application (NDA) for a novel epinephrine auto-injector, e-cue™, for emergency treatment of allergic reactions including anaphylaxis. The tentative approval of...
Pharmalucence, Inc. has received FDA approval expanding the route of administration and use of its Sulfur Colloid Injection (SCI) to include location of lymph nodes in breast cancer patients. Sulfur Colloid Injection (SCI) is a radioactive tracer manufactured by Pharmalucence which labels lymph...
Boca Pharmacal, Inc., announced that it has received approval from the FDA of its Abbreviated New Drug Application (ANDA) for Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5mg / 325mg per 5mL, the generic version of Hycet® Oral Solution distributed by FSC Laboratories, Inc...
The U.S. Food and Drug Administration approved Boostrix vaccine to prevent tetanus, diphtheria, and pertussis (whooping cough) in people ages 65 and older. Currently, there are vaccines approved for the prevention of tetanus and diphtheria that can be used in adults 65 and older. Boostrix...
Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding the resubmitted New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). In the Complete Response Letter...
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the U.S. Food and Drug Administration (FDA) clearance and limited market release of the Epiducer™ lead delivery system for neurostimulation therapy. This first-of-its-kind system allows physicians to place...
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for expansion of its BROADEN™ (BROdmann Area 25 DEep brain Neurostimulation) study for depression. This expansion will allow a maximum of 20...
Medivir AB (OMX: MVIR), is an emerging research-based specialty pharmaceutical company focused on infectious diseases. Medivir today announced that its investigational protease inhibitor TMC435 has received "Fast Track" designation by the U.S. Food and Drug Administration ("FDA") for the...
The U.S. Food and Drug Administration issued a draft guidance describing its intent to exercise enforcement discretion with respect to the premarket notification requirements for certain in vitro diagnostic and radiology devices with well-established safety and effectiveness profiles. The...
OMNIlife science, Inc. (a subsidiary of Orthopaedic Synergy, Inc.) announced clearance of its Apex PS Knee by the United States Food and Drug Administration. The Apex Posterior Stabilized (PS) Knee is the latest addition to the Apex Knee product family. The new design was introduced into the...
Breast cancer patients and their families will rally together on Tuesday, June 28, at 7:00 am outside of the Federal Drug Administration (FDA). At issue will be the FDA's final hearing to remove the anti-cancer drug Avastin from the approved medication list for treatment of late stage breast...
On behalf of the Association for Molecular Pathology (AMP), Dr. Elaine Lyon gave public comments at the US Food and Drug Administration's (FDA) meeting on "Ultra High Throughput Sequencing for Clinical Diagnostic Applications - Approaches to Assess Analytical Validity." As they begin developing...
Two decades after Rutgers scientists began working with Paul Janssen, a legendary drug developer and founder of Johnson & Johnson subsidiary Janssen Pharmaceutica, to create new and potent drugs to fight AIDS, the FDA has approved the second anti-HIV drug that came from this collaboration. "For...
Pfizer's stop-smoking drug Chantix (varenicline) can lead to a small increase in cardiovascular problems such as heart attacks for patients who already have cardiovascular disease, U.S. drug regulators said on Thursday. In fact, The Food and Drug Administration (FDA) is changing the label for...
The U.S. Food and Drug Administration today approved a new genetic test that will help health care professionals determine if women with breast cancer are HER2-positive and, therefore, candidates for Herceptin (trastuzumab), a commonly used breast cancer treatment. The test, called Inform Dual...
The U.S. Food and Drug Administration today warned women not to substitute breast thermography for mammography to screen for breast cancer. Unlike mammography, in which an X-ray of the breast is taken, thermography produces an infrared image that shows the patterns of heat and blood flow on or...
Patients' own adult stem cells show great potential in regenerative medicine, including orthopedic applications. Stem cells isolated from bone marrow can enable bone and cartilage to heal. Once removed, the patients' cells are processed and allowed to multiply in tissue culture. Then they are...
Today, U.S. Senator Herb Kohl, Chairman of the Special Committee on Aging, wrote Dr. Margaret Hamburg, Commissioner of the Food and Drug Administration (FDA) commending her Agency's recent decision to require medical device manufacturers to conduct post-market surveillance for high-risk...