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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. Read More
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). Read More
In observance of the Independence Day holiday, FDAnews will not be published Thursday, July 4. The next issue will be published Friday, July 5. Read More
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 to regulations that have been in place for decades. Read More
Three former executives of Chicago-based tech startup Outcome Health have been sentenced for their roles in a six-year scheme involving approximately $1 billion in fraudulently obtained funds gained from a pharmaceutical advertising scheme. Read More
Hoau-Yan Wang, a former paid consultant at Cassava Science and professor at the City University of New York (CUNY), is now the subject of a federal indictment charging that he milked the NIH for $16 million in grant money based on falsified data. Read More
The Supreme Court’s reversal of a 40-year-old precedent that had smoothed the regulatory agency pathway now makes it easier for courts to step in with their own interpretation of a law’s effect on regulatory issues. Read More
The FDA has published overdue draft guidance on developing diversity action plans for clinical trials, moving the agency a step closer to the statutory mandate that all phase 3 trials include such plans. Read More
The EU’s Committee for Medicinal Products for Human Use (CHMP) isn’t supporting two drugs intended to treat patients with amyotrophic lateral sclerosis (ALS) and Duchenne muscular — diseases that have also struggled to get approved treatments in the US. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Dec. 31, 2023 to keep you updated on laws and regulations that could impact your business. Read More