AbbVie Inc. (ABBV) said Friday that the European Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA has granted positive opinions for the company's investigational, all-oral, interferon-free treatment of VIEKIRAX (ombitasvir/paritaprevir/ritonavir) + EXVIERA...
Novartis AG (NVS) Friday said that the Committee for Medicinal Products for Human Use has given a positive opinion on its psoriasis drug, Cosentyx or secukinumab, for treating adults with moderate-to-severe psoriasis in Europe. The CHMP recommendation will be reviewed by the European Commission, whose...
Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi (SNYNF, SNY) Thursday said the U.S. Food and Drug Administration or FDA has granted Breakthrough Therapy designation to its investigational dupilumab, which is indicated for the treatment of adults with moderate-to-severe atopic dermatitis or AD, who...
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Bio Blast Pharma Ltd.'s (ORPN) lead product candidate Cabaletta has been granted Orphan Drug Designation by FDA for the treatment of Spinocerebellar Ataxia Type 3 (commonly known as SCA3 and Machado Joseph disease).
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The day that investors of Organovo Holdings Inc. (ONVO) have been waiting for has finally arrived!! The company on Tuesday announced the full commercial release of its exVive3D Human Liver Tissue for preclinical drug discovery testing.
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Trevena Inc.'s (TRVN) phase 2a/b trial of its drug candidate TRV130 in moderate-to-severe postoperative acute pain has achieved the primary endpoint of statistically greater pain reduction than placebo over 48 hours.
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The FDA is warning consumers not to use "Feng Shi Ling," a product promoted and sold as an herbal medication for arthritic pain associated with rheumatoid arthritis and osteoporosis, as it has been found to contain undeclared drug ingredients.
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REFA Enterprises LLC is voluntarily recalling "Forever Beautiful Bee Pollen" and "Forever Beautiful Infinity", marketed as dietary supplements for weight loss, as the products have been found to contain undeclared Sibutramine and Phenolphthalein.
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The FDA is warning consumers not to purchase or use dietary supplement Mayhem as it contains an undeclared corticosteroid - Dexamethasone - and antihistamine - Cyproheptadine.
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California Olive & Vine LLC is voluntarily recalling pumpkin seed pesto, distributed under Williams-Sonoma label, due to potential contamination with deadly bacterium Clostridium botulinum.
DateCompany NameTickerDrugEventOutcomeDetails
02/06/2015Roche Holding AGRHHBYLucentis (sBLA)FDA decision on Lucentis for the treatment of diabetic retinopathy
-Drug Status

01/24/2015Rockwell Medical Technologies IncRMTITriferic (NDA) FDA decision on Triferic for the treatment of iron replacement and maintenance of hemoglobin in hemodialysis patients
01/24/2015Rockwell Medical Technologies IncRMTITriferic (NDA)FDA decision on Triferic for treating iron deficiency in chronic kidney disease patients on hemodialysis
01/09/2015Impax Laboratories IncIPXLRYTARY (NDA)FDA decision on RYTARY for the treatment of idiopathic Parkinson's disease
-News
12/30/2014Vertex Pharmaceuticals Inc.VRTXKALYDECO (sNDA)FDA decision on KALYDECO for use in people with cystic fibrosis ages 6 and older who have R117H mutation
Submission DateCompany NameTickerDeviceCategoryOutcomeDetails
07/25/2014Guided Therapeutics, Inc.GTHP.OBLuViva Advanced Cervical Scan.PMA (Amended)
04/07/2014Myriad Genetics Inc.MYGNBRACAnalysis as a companion testPMA (First module)
04/01/2014STEREOTAXIS INCSTXSVdrive Robotic Navigation System with V-Loop Variable Loop Catheter Manipulator510(k)
02/18/2013EXACT Sciences Corp.EXASSecond module for stool DNA colorectal cancer screening test PMA
12/07/2012EXACT Sciences Corp.EXASFirst module for stool DNA colorectal cancer screening test PMA
Rockwell Medical Inc. (RMTI) has offered to sell 6.5 million shares of its common stock to the public at a price of $9.00 each. The company has also granted underwriters a 30-day option to purchase up to an additional 975,000 shares.
Amicus Therapeutics Inc. (FOLD) has offered to sell 13.85 million shares of its common stock at a price of $6.50 each. The underwriters have a 30-day option to purchase up to an additional 2.07 million shares of common stock.
Purdue Pharma LP has won approval from the FDA for its extended release, abuse deterrent hydrocodone painkiller, Hysingla ER. The pill is designed to be difficult to be crushed for snorting and prepared for injection. "While the science of abuse deterrence is still evolving, the development of opioids that are harder to abuse is helpful in addressing the public health crisis . . ."
Too much texting can cause neck wrinkles, also known as "smart phone neck," according to the American Society for Aesthetic Plastic Surgery. The study, published in the journal Surgical Technology International, found that slumping over the phone to type or read puts extra weight on the spine, leading to degeneration.

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