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Akorn Pharmaceuticals is recalling dozens of unexpired human and animal drug products in connection with a Chapter 7 bankruptcy filing, ending a five-year struggle to stay afloat through court battles and regulatory enforcement actions. Read More
Starting in September, the European Medicines Agency (EMA) will begin gradually resuming its efforts to openly share clinical trial data for medical products, the agency reported. Read More
Egypt’s Pharmaplast received an FDA warning letter on April 13 for failing to address drug component testing and equipment maintenance issues. Read More
Elkhart-Ind.-based Voyant Beauty, a division of Accra-Pac, received an FDA warning letter on April 20 for not appropriately addressing benzene contamination of its over-the-counter topical aerosol products, found during an Aug. 23-Sept. 2, 2022 inspection. Read More
The investigational drug phase 1 single-ascending dose portion initial data will no longer be reported in the second half of 2023, the company said. Read More
On Wednesday, the EU released the long-anticipated, wide-ranging revision of its drug development legislation, proposing changes that would affect nearly every part of drug development and authorization and raising opposition in the pharmaceutical industry. Read More
Twenty-four U.S. Senators have sponsored legislation that would begin the Medicare drug price negotiation enacted in the Inflation Reduction Act (IRA) sooner and increase the number of drugs included in price negotiations. Read More
Biogen has received an Accelerated Approval for Qalsody (tofersen) for the treatment of an extremely rare genetic form of amyotrophic lateral sclerosis (ALS) despite less than stellar trial results. 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
Four years after passing a state law to begin importing less pricey drugs from Canada, Florida has just filed its second lawsuit accusing the FDA of delaying authorization of the program. Read More
Though the U.S. Supreme Court has for now preserved the status quo for access to the abortion pill mifepristone, a bevy of amicus briefs filed with the court provides a glimpse into the looming fight not just over the nature of the drug itself, but of the downstream effect any decision may have on the authority and operations of the FDA. Read More