We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Republican lawmakers are renewing their push to speed FDA approvals by allowing the agency to automatically approve drugs and devices that have been approved and sold in other developed and trustworthy countries. Read More
The Ironworkers District Council of New England Health and Welfare Fund has filed a class action complaint against Teva Pharmaceuticals accusing the company of a nearly decade-long anticompetitive scheme to delay generic competition for its QVAR (beclomethasone dipropionate HFA) asthma inhalers. Read More
Ironwood Pharmaceuticals is acquiring VectivBio for $1.15 billion, netting a promising late-stage clinical asset aimed at treating severe, rare gastrointestinal conditions. Read More
The best organizations use findings from both internal audits and third-party inspections to build knowledge for future improvement — using audit data to improve the audit program itself, says Steven Lynn, executive vice president of pharmaceuticals at Regulatory Compliance Associates. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More
An FDA advisory committee turned down Intercept Pharmaceuticals’ push for an Accelerated Approval for its fatty liver drug Ocaliva (obeticholic acid) by a 15-1 vote, but did leave the door open for full approval if data from an ongoing phase 3 trial show Ocaliva’s benefits outweigh its risks. Read More
Center for Biologics Evaluation and Research (CBER) Director Peter Marks and Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni laid out their centers’ current priorities and how they’re tackling ongoing challenges in separate sessions at the FDLI Annual Conference, May 17-18. Read More
Despite lingering concerns of a potential relationship to preterm birth (PTB), an FDA advisory committee supported Pfizer’s maternal respiratory syncytial virus vaccine Abrysvo (RSVpreF) to prevent severe RSV in infants by a vote of 10-4. Read More
Over the past week, the FDA issued notices of draft guidances on pediatric research, a final decision on withdrawal of Makena and a determination on Catapres products. Read More