Chicago, Illinois – The U.S. Food and Drug Administration (FDA) has issued a Class I recall for nearly 14,000 HeartMate left ventricular assist devices (LVADs) manufactured by Abbott and its subsidiary Thoratec. This recall comes after continued concerns over safety that have been linked to multiple deaths associated with the devices. The recall specifically pertains … Read more
Boston, Massachusetts – The U.S. Food and Drug Administration (FDA) has raised concerns over the safety of Abiomed’s Impella Left Sided Blood Pumps, connecting them to 49 deaths and more than 120 serious injuries. Abiomed, a cardiovascular medical technology company wholly owned by Johnson & Johnson, faces scrutiny over its failure to notify the FDA … Read more
Washington, D.C. – Amid concerns of early patient deaths, FDA advisors have given their support to Johnson & Johnson and Legend Biotech’s Carvykti, as well as Bristol Myers Squibb’s Abecma for use in earlier stages of treatment. The panel of experts reviewed data for these CAR-T cell therapies which target cancer cells more effectively. Even … Read more
Silver Spring, Maryland – The FDA’s Oncologic Drugs Advisory Committee voted in favor of supporting the approvals of CAR-T therapies as earlier lines of treatment for multiple myeloma. Johnson & Johnson, Legend Biotech, Bristol Myers Squibb, and 2seventyBio’s therapies were discussed during the meeting, with a focus on the risks associated with early deaths in … Read more
Washington, D.C. – The FDA has raised concerns over early deaths in clinical trials for CAR-T therapies used to treat myeloma, a type of blood cancer. The trials involved Johnson & Johnson and Legend’s Carvykti, as well as Bristol Myers’ Abecma. The FDA is closely monitoring these trials to ensure patient safety and efficacy of … Read more
Silver Spring, Maryland – The FDA’s Oncologic Drugs Advisory Committee will convene on Friday, March 15th to review Johnson & Johnson and Legend Biotech Corporation’s supplemental biologics license application for Carvykti, a treatment for relapsed or refractory multiple myeloma patients. The primary focus of the meeting will be to evaluate the risk-benefit assessment of ciltacabtagene-autoleucel … Read more
San Francisco, California – The U.S. Food and Drug Administration (FDA) recently sent a warning letter to iRhythm Technologies regarding issues related to their Zio AT mobile cardiac telemetry device. The letter, dated May 25, was made public on the agency’s website on June 6, shedding light on various concerns the FDA had with the … Read more
Washington, D.C. – Arcellx’s iMMagine-1 Phase II clinical program has received approval from the FDA to resume testing its CART-ddBCMA treatment for patients with relapsed or refractory multiple myeloma, following a temporary hold on the trial earlier this year. The company announced this development on Monday, signaling a positive step forward for the innovative cell … Read more
Atlanta, GA – The recent salmonella outbreak linked to cantaloupe has officially come to an end, according to the Centers for Disease Control. The outbreak affected over 400 people in 44 states, resulting in 158 hospitalizations and six deaths. Additionally, tainted cantaloupe from the same source was also sold in Canada, where more than 160 … Read more
A Texas federal judge ruled on Friday that the Food and Drug Administration failed to follow proper procedures when approving abortion pills responsible for approximately half of all abortions performed on women in the United States. Consequently, mifepristone will be removed from the FDA’s approved list of pharmaceuticals to induce chemical abortions.