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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
Medtronic has cleared its slate of FDA objections to quality issues at its Northridge, Calif., diabetes headquarters, receiving a closeout notice from the agency to a warning letter issued in December 2021. 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
The level of Vitamin D3 in patients with melanoma has a significant effect on how those patients respond to chemotherapy with either Bristol Myers Squibb’s Opdivo (nivolumab) or Merck’s Keytruda (pembrolizumab). Read More
The FDA has placed a partial clinical hold on Foghorn Therapeutics’ phase 1 dose-escalation study of FHD-609 after a patient with synovial sarcoma developed a serious heart arrythmia while taking the second-highest dose. 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 U.S. Supreme Court on Friday weighed in on the debate over access to the abortion pill mifepristone, permitting a stay sought by the Department of Justice earlier this month and adding a layer of complexity to an already tangled tale of drug approval and access. Read More
The FDA Office of Prescription Drug Promotion (OPDP) is seeking input on its proposal to conduct research into how consumers interpret certain quantitative information about prescription drugs often included in direct-to-consumer (DTC) advertising. Read More