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Latest Therapeutics Stories

2014-07-09 23:08:49

Innovation Breakdown, a new book by Joseph V. Gulfo, details a broken system and how even the smallest changes can speed up the time to market for medical innovations that save lives. New York, NY (PRWEB) July 09, 2014 Joseph V. Gulfo​, MD MBA​ has successfully brought three medical innovations through the FDA over the course of his 25 year career. But the third time became a decade-long struggle of Herculean proportions, that included an​ unlawful ​withholding of approval by the...

2014-07-04 23:04:02

On June 30, the FDA warned not to use injectable vitamin drug products labeled “Sunshine Labs” and distributed by Medical Supply Liquidators because they are not FDA approved. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) July 04, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Injectable Vitamin...

2014-06-30 23:14:05

This seminar will provide an in-depth snapshot of the key principles and requirements for advertising and promotion expectations and ensuring compliance success by David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry. San Diego, CA (PRWEB) June 30, 2014 The FDA regulates the promotion of prescription drugs, biologics, medical devices and biotechnology products to ensure that the...

2014-06-27 23:10:35

In May 2014, the FDA released a draft guidance that covers the selection and approval process for proposed names of both prescription and nonprescription human drugs and biologics. FDAnews has teamed with drug-naming expert Dr. Susan Proulx to present a 90-minute webinar that will look closely at the draft guidance and its recommended 4-step process. Falls Church, VA (PRWEB) June 27, 2014 Choosing the Right Drug Name: How to Increase Your Chances for Approval **FDAnews Webinar** July...

2014-06-27 23:08:11

Roger Denton of Schlichter, Bogard & Denton, LLP reports that a recent lawsuit alleges that the blood thinning medication Xarelto® is linked to serious and life-threatening bleeding events. St. Louis, MO (PRWEB) June 27, 2014 According to a recent lawsuit filed in the Philadelphia County Court of Common Pleas (Stuntebeck v. Janssen Research & Development LLC et al, Case No.140201754), the anticoagulant drug Xarelto® (rivaroxaban) is alleged to cause serious and...

2014-06-26 23:16:13

On June 20, the FDA announced that all Flexi-Seal CONTROL Fecal Management System Kits are recalled (Class I) by ConvaTec, Inc. as no 510k application was submitted to FDA. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) June 26, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Flexi-Seal CONTROL Fecal...

2014-06-20 08:23:33

BUENA, N.J. and HAYWARD, Calif., June 20, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has submitted its seventh abbreviated new drug application (ANDA) in 2014 to the U.S. Food and Drug Administration (FDA). The seventh ANDA submission was in connection with an existing development, supply and marketing agreement with Impax Laboratories, Inc. (NASDAQ: IPXL). The agreement designates IGI...

2014-06-19 08:28:55

BUENA, N.J., June 19, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has submitted another abbreviated new drug application (ANDA) to the U.S. Food and Drug Administration (FDA), which brings the Company's total number of ANDA submissions in 2014 to four, with fifteen submissions now pending at the FDA. http://photos.prnewswire.com/prnvar/20130827/MM70487LOGO Jason Grenfell-Gardner,...

2014-06-19 08:28:24

REDWOOD CITY, Calif., June 19, 2014 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that senior management will present a corporate overview on June 25th. Presentation details are as follows: JMP Securities Healthcare ConferenceDate: Wednesday, June 25thLocation: The Westin New York Grand Central,...

2014-06-18 08:29:26

BUENA, N.J., June 18, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has submitted its third abbreviated new drug application (ANDA) in 2014 to the U.S. Food and Drug Administration (FDA), which brings the Company's total number of ANDA submissions to sixteen, with fourteen now pending at the FDA. http://photos.prnewswire.com/prnvar/20130827/MM70487LOGO Jason Grenfell-Gardner, President and...


Word of the Day
mundungus
  • A stinking tobacco.
  • Offal; waste animal product; organic matter unfit for consumption.
This word comes from the Spanish 'mondongo,' tripe, entrails.