News Releases
Happy Apple Company Expands Recall
Out of an abundance of caution and concern for consumer safety Happy Apples is expanding their voluntary recall of caramel apples to include Kroger Brand caramel apples produced by Happy Apple Company with a best use by date between September 15th and November 18th 2014, because it has the potential to be contaminated with Listeria monocytogenes .
Bellafill Receives FDA Approval for Treatment of Acne Scars
Suneva Medical, Inc., a privately-held aesthetics company, announced today that the U.S. Food and Drug Administration (FDA) has approved the dermal filler, Bellafill®, for the treatment of acne scars.
FDA Approves New Treatment for PAD in Upper Leg
Medtronic, Inc. (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has approved the company's IN.PACT Admiral drug-coated balloon (DCB) for the interventional treatment of peripheral artery disease (PAD) in the upper leg.
Diabetic Nephropathy Rx Found Safe for Heart
NephroGenex, Inc. (Nasdaq:NRX), a pharmaceutical company focused on the development of therapeutics to treat kidney disease, today announced the Company has successfully completed a thorough QT/QTc (TQT) cardiac safety study on Pyridorin.
NeuroDerm Parkinson's Rx Shows Promise
NeuroDerm Ltd. (NASDAQ: NDRM), a clinical-stage pharmaceutical company developing drugs for central nervous system (CNS) diseases, today announced that continuous, subcutaneous delivery of the company’s proprietary liquid levodopa/carbidopa (LD/CD) product candidates, ND0612H and ND0612L, led to clinically-significant plasma levodopa levels. These results suggest that the high dose version, ND0612H, intended for severe Parkinson’s disease patients, may provide an effective therapy alternative to current treatments requiring surgery.
BioCryst's Rapivab Receives FDA Approval for the Treatment of Acute Uncomplicated Influenza
BioCryst Pharmaceuticals, Inc., (Nasdaq:BCRX) a pharmaceutical company focused on the development and commercialization of treatments for rare and infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved RAPIVAB (peramivir injection), an intravenous (i.v.) neuraminidase inhibitor for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than two days.
FDA Approves Treatment for Children With Allergic Rhinitis
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) announced today that the U.S. Food and Drug Administration (FDA) approved QNASL® (beclomethasone dipropionate) 40 mcg for the treatment of nasal symptoms associated with allergic rhinitis (AR) in children 4-11 years of age.
Bleating Heart Cheese Recalls Various Cheeses
Bleating Heart Cheese (BHC) is conducting a voluntary recall of a few of its sheep milk and cow’s milk cheese produced in late May, late June and early July of 2014, based on sampling by the US Food & Drug Administration (FDA) that found the presence of Listeria monocytogenes in at least one sample of the following cheeses.
Tetraphase Announces Positive Top-line Results from Phase 3 IGNITE 1 Clinical Trial of Eravacycline in Complicated Intra-abdominal Infections
Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced positive top-line results from IGNITE 1, the Company's Phase 3 clinical trial of eravacycline for the treatment of complicated intra-abdominal infection (cIAI) compared to ertapenem.
Pfizer Initiates Phase 2 Study of PF-06252616 in Duchenne Muscular Dystrophy
Pfizer Inc. (NYSE:PFE) announced today enrollment of the first patient in a multicenter Phase II clinical trial of the investigational compound PF-06252616 in boys with Duchenne muscular dystrophy (DMD), a genetic disorder characterized by progressive muscle degeneration and weakness. PF-06252616 is an experimental, infused, anti-myostatin monoclonal antibody.