The chart below identifies 6 new FDA Products Receiving Orphan Designation for the week of 05/18 – 05/22/15 as of 05/22/15 in ascending “Orphan Drug Designation Date” order. 109 more words
Tags » Rare Disease
PlasmaTech Biopharmaceuticals, a Dallas-based biopharmaceutical company focusing on protein biologic therapies and oncology supportive care products, announces on May 20th, that the FDA has granted Rare Pediatric Disease Designations to both of their investigational Gene Therapy products for Sanfilippo Syndrome (SF), MPS IIIB and MPS IIIA: 221 more words
The European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) held a meeting May 12 – 13, 2015.
At this meeting, there are 11 positive opinions recommending the following medicines for designation as orphan medicinal products. 248 more words
As of today, May 19th, 2015, Cynthia Prentice will now be taking over Dercum’s Disease Resources! Many of you are already familiar with Cynthia from her avid involvement with Dercum’s Disease awareness, through Facebook, or from the early days of communicating about DD via “forums” on the internet. 149 more words
The CBER BTD #s are current as of 04/30/15 and the CDER BTD #s are current as of 05/15/15.
The changes are as follows:
• The total # of FDA CDER + CBER BTD Requests received by the FDA increases from 300 to 304… 158 more words