Senator Bill Cassidy (R-LA), ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, called out the FDA in a letter pressing federal agencies on how they will…
An Indian plant that makes a number of drugs and active pharmaceutical ingredients (API) was socked with a six-observation Form 483 noting multiple problems with validation testing for API and…
This week, the FDA published a final guidance for small businesses on LDTs. The long-awaited draft guidance on diversity in clinical trials was also published. The agency modified its list…
It looks like glucagon-like peptide 1 receptor agonists (GLP-1) are pulling another trick out of their seemingly bottomless black bag. In addition to regulating blood sugar, trimming fat and cutting…
Manufacturers of laboratory-developed tests (LDT) are concerned that the FDA will lack the resources to deal with a flood of premarket approval applications as the agency implements its recent final…
A new analysis by Milliman commissioned by PhRMA indicates that 3.5 million Medicare Part D beneficiaries could face an average 12 percent increase in annual out-of-pocket costs in 2026 due…
The FDA on Tuesday approved Kisunla (donanemab-azbt), Eli Lilly’s once-monthly injection for adults with early symptomatic Alzheimer's disease (AD), along with earlier approvals of four other drugs for various conditions.…
The FDA has issued a complete response letter (CRL) to Rocket Pharmaceuticals requesting additional chemistry, manufacturing and controls (CMC) information before reviewing the company’s BLA for Kresladi (marnetegragene autotemcel). Source:…
The Supreme Court voted 6-3 on Monday to lay out a new standard that makes it easier for companies and other entities to challenge federal rules, potentially allowing new challenges…
CDRH has again expanded the Total Product Life Cycle Advisory Program (TAP), adding devices reviewed in three additional FDA offices. Source: Drug Industry Daily