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Vanda Pharmaceuticals is suing the FDA, charging that the agency illegally revealed proprietary manufacturing information to companies seeking approval for generic forms of two of Vanda’s patented drugs. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from medical device enforcement, real-world evidence and root cause analysis. Read More
New digital technologies that enable clinical trials to take place in locations other than traditional trial sites are the subject of a long-awaited FDA draft guidance on conducting decentralized trials (DCT). Read More
A group of 26 state attorneys general joined the outcry against Medicare’s ongoing payment restrictions on antiamyloid antibody Alzheimer’s therapeutics, sending a letter to HHS last week calling for full coverage of the drugs. Read More
The FDA’s Breakthrough Device program, launched in 2018 to meet two agency aims — encouraging innovative devices in areas of greatest need and bringing them to market more quickly — has so far achieved only one. The “fast track” to patient availability has not materialized, regulatory experts say. Read More
After heated delays involving a competitor and the FDA, Dublin-based Avadel Pharmaceuticals has won FDA approval for Lumryz, its extended-release formulation of sodium oxybate for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy. Read More
As the 118th Congress continues, FDAnews will be tracking the important pieces of pending legislation to keep you updated on regulations that could impact your business. Read More
The FDA outlined its latest thinking on developing nicotine replacement therapy (NRT) drugs in a final guidance released Monday, including detailed recommendations for clinical trials to support product applications. Read More
Astellas Pharma has acquired Iveric Bio in a $5.9 billion deal that brings the Japanese biotech Iveric’s avacincaptad pegol (ACP), an investigational intraocular injection for geographic atrophy secondary to age-related macular degeneration. Read More
Ascendis Pharma of Denmark got slapped with a Complete Response Letter (CRL) in which the FDA voiced concerns about the variability in the delivered dose of the company’s investigational treatment for adults with hypoparathyroidism. Read More
The UK plans to extend its acceptance of CE-marked devices through at least 2028, pushing back the current June 30 deadline for devices to comply with the UK’s post-Brexit equivalent. Read More
The FDA’s ability to function is threatened by the loss of public respect for the agency’s science-based decision making, which is “arguably at an all-time low,” said Steven Grossman, executive director of the Alliance for a Stronger FDA. Read More