To help device manufacturers avoid the most common reasons for delays in technical documentation reviews — incomplete submissions and a lack of cohesive structure — the nonprofit European Association of…
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…
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…
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…
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. Source:…
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…
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…
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…
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…
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…