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In his fiscal year 2017 budget, President Barack Obama says he will seek more than $1 billion in mandatory funding over two years to help combat prescription opioid abuse. Read More
Two Oregon supplement makers are in the FDA’s crosshairs for marketing their products for a range of unapproved conditions, including regulating blood pressure and alleviating panic attacks. Read More
Turing Pharmaceuticals and Valeant Pharmaceuticals lined “their pockets at the expense of some of the most vulnerable families in our nation,” House Oversight Committee Ranking Member Elijah Cummings (D-Md.) says in a memo to committee members. Read More
In a rare warning letter to an institutional review board, CDER’s Office of Scientific Investigations contends that an IRB at Monmouth Medical Center was lax in supervising research at the facility. Read More
Telesta Therapeutics has received a complete response letter from the FDA, informing the company that its BLA for Mycobacterium phlei cell wall-nucleic acid complex would need an additional Phase 3 clinical trial to adequately establish the candidate’s efficacy and safety. Read More
CBER Requests Help From Industry for Staff Training Program
FDA AdComm to Review Acadia’s Parkinson’s Disease Candidate
Proteostasis Therapeutics’ Cystic Fibrosis Treatment Garners FDA Fast Track
Ryanodex Garners FDA Fast Track Status Read More
The European Medicines Agency is asking for feedback on a revised guideline for the treatment of Alzheimer’s disease and other types of dementia. Read More
Novartis now faces competition to its top-seller Gleevec, a treatment for chronic myeloid leukemia, as Sun Pharma launched its copycat version in the U.S. Monday. Read More