Nov 26 (Reuters) - The U.S. Food and Drug Administration rejected Avanir Pharmaceuticals Inc's migraine drug device, a few weeks after the regulator had raised questions regarding some data submitted...
(Adds details on drug, other Bristol-Myers, rival treatments)
Nov 26 (Reuters) - Bristol-Myers Squibb Co on Wednesday said U.S. regulators had declined to approve use of its experimental daclatasvir drug for hepatitis C, in combination with other antiviral drugs.
* Said on Monday Janssen Research & Development LLC submitted a New Drug Application (NDA) for Yondelis to the U.S. Food and Drug Administration for the treatment of patients with advanced soft tissue sarcoma (STS)
ZURICH, Nov 25 (Reuters) - Swiss drugmaker Novartis AG said on Tuesday the U.S. Food and Drug Administration ( FDA ) had extended a priority review period by up to three months for a new drug application for the treatment of a type of bone marrow cancer.
SAN FRANCISCO, Nov 24 (Reuters) - A draft U.S. bill is circulating in Washington D.C. that would curb the U.S. Food and Drug Administration 's regulatory oversight over electronic medical records and...
WASHINGTON, Nov 24 (Reuters) - The U.S. Food and Drug Administration has tightened its guidelines on the use of a uterine surgical technique, saying it has been linked to the spread of a rare type of cancer.
BioMarin's portfolio of rare disease therapies. While the DMD landscape is poised to become competitive--Sarepta is completing its FDA filing for similar drug eteplirsen in the middle of 2015—we think BioMarin's backing and potential first-to-market position
(In Nov. 20 story, corrects final paragraph to show Embeda treats pain, not opioid dependence)
* Reports that U.S. FDA sets date of advisory committee meeting on isavuconazole NDA for the treatment of invasive aspergillosis and mucormycosis