Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Friday, May 24, 2013

Repros Therapeutics Gets FDA OK For Phase 2b Trial of Proellex(R)-V

Repros Therapeutics Inc., located in The Woodlands, Texas, met with the FDA to discuss clinical development of Proellex-V (telapristone). Proellex-V is a product that is administered to the vagina to treat uterine fibroids.

http://bionews-tx.com/news/2013/05/24/repros-therapeutics-gets-fda-ok-for-phase-2b-trial-of-proellexr-v/

Monday, February 18, 2013

Celltex Therapeutics Begins Cooperation With FDA to Resume Stem Cell Treatments

Texas-based adult stem cell treatment provider Celltex is apparently making strides in winning approval from the FDA, according to a recent wide-ranging article from Nature.com that outlines the controversial past and present of adult stem cell research and treatment. As a result of close scrutiny from the FDA in 2012 over what the organization deemed to be unproven treatment methods using adult stem cells, Celltex was forced to capitulate. After failing to argue effectively that stem cell treatments are in essence “tissue transplants” and not traditional drug treatments, thus not requiring the same rigorous clinical trials, the company was forced to move its treatment facilities to Mexico in order to continue to offer its patients ongoing stem cell treatment.

http://www.swbiosearch.com/2013/02/18/celltex-therapeutics-begins-cooperation-with-fda-toresume-stem-cell-treatments/

Thursday, January 17, 2013

FDA Approves Innovative Flublok Flu Vaccine

The Flublok flu vaccine can be mass-produced quickly to respond to epidemic flu outbreaks, and protects against a wide range of influenza strands.

http://www.swbiosearch.com/2013/01/17/fda-approves-innovative-flublok-flu-vaccine/