Latest U.S. Food and Drug Administration Stories

PRINCETON, N.J., May 15, 2013 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there remains an unmet medical need, announced today that it has initiated the first clinical study for development of SGX203 (oral beclomethasone 17,21-dipropionate or oral BDP) for the treatment of pediatric Crohn's disease. The program has...

Quarterly Index Finds Foreign Objects Responsible for 28 Percent of USDA Recalls; Sports Equipment Recalls Rising INDIANAPOLIS, May 15, 2013 /PRNewswire/ -- According to the ExpertRECALL Index released today, nearly three out of four food recalls in the first quarter of this year were issued by companies facing two or more recalls during the 90-day period, a situation that is taxing the resources of food companies to successfully navigate the logistical challenges and regulatory...

PARSIPPANY, N.J., May 13, 2013 /PRNewswire/ -- Actavis, Inc. (NYSE: ACT) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Actavis' New Drug Application (NDA) for a progestin-only transdermal contraceptive patch (Norethindrone Transdermal Delivery System) for use by women to prevent pregnancy. The acceptance of the NDA for filing means FDA has determined that the application is sufficiently complete to permit a substantive review. The...

RARITAN, N.J., May 13, 2013 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) for simeprevir (TMC435), an investigational NS3/4A protease inhibitor administered as a 150 mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease. Hepatitis...

Consumers can contact Resource4thePeople's national network of attorneys for free consultations about their legal options to join with those seeking compensation for alleged side effects, including deep vein thrombosis, filter fracture, migration and perforation. San Diego, CA (PRWEB) May 11, 2013 http://www.resource4thepeople.com/defectivemedicaldevices/bard-ivc.html Resource4thePeople announced today a consumer update of the progress of litigation involving claims that patients who...

An Intuitive Surgical training specialist said she focused on teaching doctors how to use the da Vinci surgical robot, not how to operate on patients, according to Bloomberg. Training is a key issue in the ongoing Washington state trial, as the Plaintiff is alleging that the training program provided by Intuitive for the da Vinci was compromised by aggressive marketing. New York, New York (PRWEB) May 10, 2013 Parker Waichman LLP, a national law firm dedicated to protecting the rights of...

MALVERN, Pa., May 10, 2013 /PRNewswire/ -- Endo Health Solutions Inc. (Nasdaq: ENDP) announced today that the U.S. Food and Drug Administration (FDA) has denied a Citizen Petition filed by its subsidiary, Endo Pharmaceuticals Inc. Endo presented FDA data collected from an ongoing epidemiology study that indicate that per 100,000 prescriptions dispensed, the past 30-day abuse rate of crush-resistant OPANA ER was 79 percent lower than the abuse rate of generic versions of...

WASHINGTON, May 8, 2013 /PRNewswire-USNewswire/ -- The Pew Charitable Trusts today applauded Senators Kirsten Gillibrand (D-NY), Dianne Feinstein (D-CA), and Susan Collins (R-ME), for introducing the Antimicrobial Data Collection Act, which would require the U.S. Food and Drug Administration, or FDA, to report more information on the annual sales of antibiotics used among industrial farm animals. The bipartisan bill would also give the agency a deadline to finalize policies proposed last...

SAN DIEGO, May 7, 2013 /PRNewswire/ -- Aethlon Medical, Inc. (OTCQB: AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce. Through the publication of CEO notes, I seek to provide shareholders and other interested parties with a level of corporate transparency often absent in the microcap marketplace. In recent notes, I reviewed various topics, including emerging opportunities in cancer and the expansion of our government contract program to create a...

- Interferon-free, direct-acting antiviral combination therapy currently in Phase 3 development NORTH CHICAGO, Ill., May 6, 2013 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that its investigational direct-acting antiviral (DAA) combination with and without ribavirin for the treatment of genotype 1 (GT1) hepatitis C virus (HCV) infection has been designated as a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA). The designation is based, in part, on...