Washington, D.C. – The U.S. Food and Drug Administration (FDA) issued a Class I recall on nearly 14,000 HeartMate left ventricular assist devices (LVADs) manufactured by Abbott and Thoratec, citing safety concerns that have led to multiple deaths. The recall includes both the HeartMate II LVAD and HeartMate 3 LVAD due to the gradual buildup … Read more
Boston, Massachusetts – The FDA investigation has uncovered alarming findings regarding Abiomed’s Impella Left Sided Blood Pumps, linking them to at least 49 deaths and over 120 serious injuries. Abiomed, a cardiovascular medical technology company fully owned by Johnson & Johnson, has come under scrutiny for failing to disclose risks associated with the device. Despite … Read more
Washington, D.C. – An FDA advisory panel has recommended the approval of two groundbreaking cancer treatments, Carvykti and Abecma, for use in earlier stages of the disease. This decision comes despite initial concerns about potential risks associated with the treatments. Carvykti, developed by J&J and Legend, and Abecma, developed by BMS, have shown promising results … Read more
Silver Spring, Maryland – FDA’s Oncologic Drugs Advisory Committee recently voted to support the approvals of CAR-T therapies – Johnson & Johnson and Legend Biotech’s Carvykti and Bristol Myers Squibb and 2seventyBio’s Abcema – as earlier lines of treatment for multiple myeloma. The committee’s decision came after discussing the risks of early death in the … Read more
Washington, D.C. – The Food and Drug Administration (FDA) has raised concerns over early deaths observed in clinical trials for CAR-T cell therapies by Johnson & Johnson (J&J), Legend’s Carvykti, and Bristol Myers’ Abecma targeting patients with myeloma. These groundbreaking treatments are designed to utilize a patient’s own immune cells to fight cancer. CAR-T therapy … Read more
Washington, D.C. — The FDA’s Oncologic Drugs Advisory Committee is set to convene on Friday to deliberate on Johnson & Johnson and Legend Biotech Corporation’s supplemental biologics license application for Carvykti. This drug is intended for patients with relapsed or refractory multiple myeloma who have undergone previous lines of therapy. The panel will specifically analyze … Read more
San Francisco, California – The U.S. Food and Drug Administration (FDA) recently issued a warning letter to iRhythm Technologies over violations related to its Zio AT mobile cardiac telemetry device. The letter, published on the FDA’s website, outlined various concerns, including the company’s failure to report patient deaths and other violations within the required timeframe. … Read more
LOS ANGELES, CALIFORNIA – An outbreak of drug-resistant bacteria linked to certain brands of eye drops has led to multiple deaths and cases of blindness, prompting recalls of the affected products, the Food and Drug Administration reported. According to the Centers for Disease Control and Prevention, 81 patients across 18 states have been infected with … Read more
WASHINGTON D.C. – The FDA has cleared Arcellx to resume its iMMagine-1 Phase II clinical program for its CART-ddBCMA treatment following a partial clinical hold. This treatment is for patients with relapsed or refractory multiple myeloma. The trial, which is being carried out in collaboration with Gilead’s Kite Pharma, had been put on hold in … Read more
Sen. Bill Cassidy (R-La.) stated on Sunday that claims the FDA’s approval of the abortion medication mifepristone will be disrupted by the judge’s decision to halt the approval process temporarily were unfounded.