FDA

April 17, 2015September 28, 2016

FDA Authorizes Soligenix’s Pivotal Phase 3 Clinical Trial for Pediatric Crohn’s Disease Therapy

Crohn's Disease, News

Biopharmaceutical company Soligenix, Inc. recently announced in a news release that the U.S. Food and Drug Administration (FDA) has authorized a pivotal Phase 3 clinical trial to assess the efficacy ... Read more

January 27, 2015January 27, 2015

Cellceutix Seeks FDA’s Advice on Ulcerative Proctitis Therapy

News

Clinical stage biopharmaceutical company, Cellceutix Corporation, is submitting a request to the U.S. Food and Drug Administration (FDA) for a pre-Investigational New Drug (IND) meeting. The company, which is dedicated to developing novel treatments with oncology, ... Read more

November 13, 2014November 13, 2014

TiGenix Completes Phase 3 Cx601 Trial Enrollment in Europe

News

Leading European cell therapy company TiGenix NV has just announced the successful full enrollment of patients for a Phase III clinical trial of Cx601, the company’s pipeline treatment for complex perianal fistulas ... Read more

October 10, 2014October 10, 2014

FDA Grants Salix’s UCERIS Rectal Foam for Ulcerative Colitis Final Approval

News, Ulcerative colitis

The U.S. Food and Drug Administration (FDA) recently approved UCERIS (budesonide) rectal foam, developed by Salix Pharmaceuticals, to induce remission in patients suffering from active mild-to-moderate distal ulcerative colitis (UC) extended up to ... Read more

September 22, 2014September 28, 2016

Salix’s UCERIS Granted Tentative FDA Approval for Distal Ulcerative Colitis

News, Ulcerative colitis

Salix Pharmaceuticals may soon bring a new treatment for mild-to-moderate distal ulcerative colitis to the market with its tentative Food and Drug Administration (FDA) approval for UCERIS (budesonide) rectal foam. ... Read more

July 3, 2014

Takeda’s Entyvio Approved By FDA for Ulcerative Colitis, Crohn’s Disease

Crohn's Disease, News, Ulcerative colitis

The Entyvio (vedolizumab) injection to treat adult patients with moderate to severe ulcerative colitis (UC) and Crohn‘s disease (CD) was recently approved by the U.S. Food and Drug Administration. The drug, which was ... Read more