FDA Archives - Loyal Conservatives

HeartMate Devices Linked to Injuries and Deaths Receive FDA Recall

MIAMI, FL – The Food and Drug Administration has issued its most serious recall for two heart devices due to their connection to numerous injuries and deaths. The HeartMate 2 and HeartMate 3, manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories, have been linked to at least 14 deaths and over 4,500 reports of potential harm. These mechanical heart pumps are crucial for patients with end-stage heart failure who are awaiting a transplant or …

FDA Recalls Abbott and Thoratec HeartMate LVADs Due to Safety Concerns

Washington, D.C. – The U.S. Food and Drug Administration (FDA) has issued a Class I recall alerting the public about the safety risks associated with Abbott and Thoratec’s HeartMate left ventricular assist devices (LVADs). Nearly 14,000 devices are being recalled due to concerns over the gradual buildup of biological materials within the devices, which can lead to serious health complications and, in some cases, fatal outcomes. The FDA’s announcement follows reports of 14 deaths and …

Abiomed’s Impella Heart Pump Linked to 49 Deaths and FDA Investigations

Baltimore, Maryland – The U.S. Food and Drug Administration (FDA) has recently raised concerns over Abiomed’s Impella Left Sided Blood Pumps, linking them to at least 49 deaths and over 120 serious injuries. According to reports, Abiomed, a cardiovascular medical technology company owned by Johnson & Johnson, failed to inform the FDA of the risk that the device can perforate the walls of the heart, resulting in numerous injuries. The FDA issued a warning letter …

FDA Advisers Overwhelmingly Approve Carvykti and Abecma for Earlier Treatment Options

Washington, D.C. – A recent update on FDA advisers’ decisions regarding J&J and Legend’s Carvykti and BMS’ Abecma has sparked discussions in the medical community. Despite initial concerns about potential adverse effects leading to earlier deaths, the FDA advisers have ultimately backed these medications for a wider range of use. Carvykti and Abecma, two innovative treatments, have shown promising results in managing certain health conditions. The decision to support these drugs for earlier administration signifies …

FDA Panel Overwhelmingly Supports CAR-T Therapies for Multiple Myeloma Treatment

Silver Spring, Maryland – The FDA’s Oncologic Drugs Advisory Committee discussed the risks and benefits of CAR-T therapies developed by Johnson & Johnson, Legend Biotech, Bristol Myers Squibb, and 2seventyBio for the treatment of multiple myeloma. The committee voted in support of Carvykti and Abecma as earlier lines of treatment, despite concerns about early deaths in the trials. During the meeting, experts evaluated the data from the trials, noting a higher rate of early deaths …

CAR-T Therapy Trials for Multiple Myeloma Face FDA Scrutiny After Early Deaths

Boston, MA – The Food and Drug Administration (FDA) has raised concerns about early deaths in clinical trials for CAR-T cell therapies in multiple myeloma patients. The trials in question involve Johnson & Johnson’s Carvykti and Legend Biotech’s Carvykti, as well as Bristol Myers Squibb’s Abecma. CAR-T cell therapies have shown promise in treating certain types of cancer by genetically modifying a patient’s own immune cells to attack cancer cells. However, the FDA is now …

JNJ and LEGN FDA Meeting: Risks and Benefits of New Cancer Treatment for Multiple Myeloma Evaluated

Washington, DC – On Friday, the FDA’s Oncologic Drugs Advisory Committee is set to convene to review Johnson & Johnson and Legend Biotech Corporation’s supplemental biologics license application for Carvykti for the treatment of relapsed or refractory multiple myeloma. The discussion will focus on the efficacy and safety of ciltacabtagene autoleucel, also known as cilta-cel, in patients who have undergone at least one prior line of therapy. One key point of contention will be the …

Recall Alert: Eye Drops Linked to Blindness and Death – FDA Issues Urgent Warning

Los Angeles, California – An outbreak of drug-resistant bacteria linked to several eye drop brands has resulted in four deaths and multiple cases of blindness, according to the Food and Drug Administration. The Centers for Disease Control and Prevention reported that 14 individuals have lost their vision, with four having their eyeballs removed due to the bacteria, known as Pseudomonas aeruginosa. As of May 15, 81 patients across 18 states have been affected by the …