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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
Bluebird Bio is pulling out all the regulatory stops for its investigational sickle cell disease (SCD) gene therapy lovotibeglogene autotemcel (lovo-cel), submitting a BLA with a request for priority review in addition to the four expedited approval designations the FDA had already granted the drug. Read More
The European Medicines Agency (EMA) has become the first regulator to accept the International Council for Harmonization (ICH) S12 guideline, laying out the council’s recommendations for how to conduct nonclinical biodistribution (BD) studies when developing gene therapy products. Read More
More than half of the best-selling brand-name drugs covered by Medicare may not provide significant added therapeutic benefits despite comprising a large portion of the federal agency’s spending, according to results of a study published in JAMA Network this week. Read More
Over the past week, the FDA issued a correction of a docket, an authorization and two revocations of diagnostic devices and a request for comments on rapid response surveys. In addition, the agency announced a public workshop. Read More
mRNA developer Moderna and computer giant IBM have announced an agreement under which Moderna will explore next-generation technologies, including quantum computing and artificial intelligence (AI), to accelerate mRNA research and science. Read More