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…
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 —…
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…
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. Source: Drug Industry Daily
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. Source:…
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…
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…
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.…
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…
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 11 to 1 with one abstention to recommend that the FDA restrict approval for the combination of AstraZeneca’s blockbuster cancer drug Lynparza…