Boxed Warning for Adzynma Enzyme Replacement

FDA says it has directed Takeda to add a Boxed Warning to the labeling for its Adzynma, a recombinant ADAMTS13 enzyme replacement therapy approved for congenital thrombotic thrombocytopenic purpura (cTTP). An agency online notice says Adzynma has been associated with the development of neutralizing antibodies that can prevent the drug

Overton Pledges Science-Based FDA Decisions at Confirmation Hearing

FDA commissioner nominee Heidi Overton pledged to accelerate drug development, strengthen regulatory oversight and preserve the agency's scientific independence during her Senate confirmation hearing Thursday, while facing pointed questions from lawmakers about vaccine safety, medication abortion, tobacco regulation and political interference in FDA decisions. Overton, a White House

Lilly Once-Weekly Insulin Injection Approved

FDA has approved Eli Lilly’s Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin injection for controlling high blood sugar in adults with Type 2 diabetes when used along with diet and exercise. Onswik is designed to deliver steady basal insulin levels over a full seven days, the

Robotically Assisted Surgical Devices Guidance

FDA Approves Advanced Renal Cell Cancer Treatment

Gottlieb TV Appearance Endorses Overton FDA Nomination

On the eve of FDA commissioner-nominee Heidi Overton’s Senate confirmation hearing, Former FDA head Scott Gottlieb appeared on CNBC to offer his ringing endorsement of President Trump’s pick to lead the agency. Gottlieb cited as being positive her White House experience, relationships with administration officials, and her

FDA Accepts Wearable Sensor-Based Foot Drop Measure for Trials

FDA has accepted a letter of intent (LOI) for a wearable sensor-based digital outcome measure designed to assess foot drop severity and gait impairment in patients with Charcot-Marie-Tooth disease type 1A (CMT1A), marking the first digital health technology for a rare neurological condition accepted into the agency&

Proteomic Biomarker Framework to Speed Drug Development

FDA says efforts by CDER scientists to develop a systematic plasma proteomic biomarker framework can accelerate drug development by providing early mechanistic insights into therapeutic effects and enabling more informed decision-making in clinical trials through the selection of robust, biologically relevant biomarkers. An online post says that to evaluate

Improve ‘Substantial Effectiveness’ Draft Guidance: Stakeholders

Four stakeholders are suggesting ways FDA could improve its draft guidance on substantial evidence of effectiveness for human drug and biological products. The Center for Science in the Public Interest (CSPI) says it “opposes any shift in the regulatory standard to a one-trial default….” While the draft does not

FDA Panel Backs Grail's Galleri Multi-Cancer Blood Test

An FDA advisory committee voted Wednesday to recommend approval of Grail's Galleri multi-cancer early detection blood test, voting unanimously, 10-0, that the test is safe, 6-4 that it is effective, and 7-2, with one abstention, that its benefits outweigh its risks for screening adults

Multiple Types of Violations at Specialty Health Products

A 12/1-12/11/2025 FDA inspection at Specialty Health Products in Phoenix, AZ, found multiple violations in the firm’s illegal manufacturing of colonic irrigation systems and speculum kits. A just-released 7/7 Warning Letter lists these Quality System Regulation violations: * failure to establish and maintain design

Are Comparative Clinical Studies of Biologics Worth the Time and Cost?

FDA says a meta-analysis conducted by CDER scientists found that pharmacokinetic similarity studies provided useful information to descriptively evaluate the immunogenicity and safety of biologics, and that comparative clinical studies did not appear to be more definitive. In an online post, the agency says the scientists suggest that their