We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA approved Amgen’s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to AstraZeneca’s Soliris (eculizumab) to treat the rare diseases paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Read More
The final version of an International Council of Harmonisation (ICH) guideline that addresses evaluation of the drug-drug interaction (DDI) potential of an investigational drug is ready for adoption and a draft of a guideline on general principles for planning pharmacoepidemiological studies is ready for review. Read More
An FDA advisory committee voted 7-4 that the risk of serious hypoglycemia seen with Novo Nordisk’s Awiqli insulin outweighed the convenience of its once-a-week dosing regimen for people with type 1 diabetes. Read More
Believing “this bill protects women across Louisiana,” Gov. Jeff Landry on Friday signed state legislation classifying the abortion-inducing drugs mifepristone and misoprostol as controlled substances. Read More
The FDA’s draft guidance on platform technology designations for drug development outlines how sponsors can submit a designation request and the benefits of the designation. Read More
Eli Lilly announced on Friday that it has more than doubled its investment in its Lebanon, Ind., manufacturing site with a $5.3 billion commitment that will expand its capacity to make active pharmaceutical ingredients (API) for tirzepatide (Mounjaro and Zepbound) as well its pipeline drugs. Read More
The FDA needs to regain the authority to regulate drugs used in executions, according to nine Democratic senators who Tuesday wrote separate letters to FDA Commissioner Robert Califf and Drug Enforcement Administration (DEA) Administrator Anne Milgram. Read More
The collaborative efforts that advance the development of more generic drugs is the work of CDER’s science and research program whose 2023 annual report provides details on the efforts behind the issuance of 244 new and revised product specific guidances (PSG), including 174 for complex products. Read More
This week, the FDA issued a final rule reclassifying ultrasound cyclodestructive devices and published a notice seeking nominations for advisory panels of the Medical Devices Advisory Committee. Read More