Latest Food and Drug Administration Stories

Two Steps Closer to a Viable Treatment for Spinal Cord Injuries GREENWICH, Conn., April 5, 2013 /PRNewswire/ -- Spencer Trask, a venture capital firm focused on developing big ideas into world-changing companies, congratulates InVivo Therapeutics (NVIV), for its recent approvals from the U.S. Food and Drug Administration (FDA). On the heels of FDA approval for Humanitarian Use Device (HUD) designation (an important benchmark and speed-to-market catalyst), InVivo has received yet...

Lee Rannals for redOrbit.com - Your Universe Online A federal judge has decided to make the "morning after" emergency contraception pill available to all girls of reproductive age. The judge ordered the Food and Drug Administration (FDA) to make the pill available without a prescription to all girls. The order reverses a December 2011 decision by US Health and Human Services Secretary Kathleen Sebelius to limit the pill without prescription to women age 17 and older. District Judge...

SAN DIEGO, April 5, 2013 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today the initiation of dosing in a Phase 1 clinical trial of APD334, a novel oral drug candidate that targets the sphingosine 1-phosphate subtype 1 (S1P(1)) receptor for the potential treatment of autoimmune diseases. This randomized, double-blind and placebo-controlled Phase 1 trial will evaluate the safety, tolerability and pharmacokinetics of single-ascending doses of APD334 in up to 64...

-- Patent Expands Company's Patent Portfolio to Include Combination with Number One Selling Multiple Sclerosis Drug -- ROCKVILLE, Md., April 4, 2013 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of synthetic biologics and innovative medicines for serious infections and diseases, announced today that the U.S. Patent & Trademark Office has issued U.S. Patent No. 8,372,826 entitled, Estriol Therapy for Multiple Sclerosis and Other Autoimmune...

Major milestone achieved as orphan status grants Enlivex seven years of exclusivity for treatment based on immune tolerance for GVHD JERUSALEM, April 4, 2013 /PRNewswire/ -- Hadasit Bio-Holdings Ltd. (TASE: HDST, OTC: HADSY), a publicly traded portfolio of biotech companies, all based on intellectual property developed and owned by Hadassah University Hospital, Israel's foremost medical research center, announced today that one of its flagship portfolio companies, Enlivex...

New Adaptor Allows Use with Early Access Arterial Grafts ATLANTA, April 4, 2013 /PRNewswire/ -- CryoLife, Inc. (NYSE: CRY), a leading tissue processing and medical device company focused on cardiac and vascular surgery, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for a next generation HeRO (Hemodialysis Reliable Outflow) device. The HeRO device is the only subcutaneous AV access solution clinically proven to maintain long-term access...

PITTSBURGH, April 3, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Acyclovir Ointment USP, 5%. This product is the first generic version of Valeant International's Zovirax(® )Ointment, which is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous...

-FDA trend experts will present and answer questions- SALT LAKE CITY, April 3, 2013 /PRNewswire/ -- Nelson Laboratories (www.nelsonlabs.com) will give pharmaceutical industry professionals direct access to its FDA trend experts during the "The Science of Pharmaceutical Microbiology Seminar" on May 16, 2013 in San Diego, Calif. (Logo:  http://photos.prnewswire.com/prnh/20120727/LA47745LOGO) "We created this seminar to impart our industry knowledge on microbial control and aseptic...

Activists to Prepare & Share "Stone Soup" to Protest FDA's Antiquated Policies on Genetically Engineered (GMO) Foods COLLEGE PARK, Md., April 3, 2013 /PRNewswire-USNewswire/ -- The following is being released by Occupy Monsanto: Alarmed by the Food and Drug Administration's (FDA) outdated and pro-biotechnology industry policies concerning the labeling & safety of GMO foods sold in America, safe food activists will hold the largest protest to date at the FDA to demand...

LISBON, Portugal, April 3, 2013 /PRNewswire/ -- Hovione today announced a co-promotion and collaboration agreement with Ligand to provide Hovione's customers efficient access to Captisol(R) technology. Captisol, a chemically modified cyclodextrin, is proven to improve the solubility and stability of drugs and is currently used in six marketed products. Hovione offers innovative particle engineering technologies to improve the solubility of modern drugs. The agreement...