WASHINGTON — The U.S. Food and Drug Administration has issued an alert concerning a rare, yet severe, allergic reaction possibly linked to certain drugs used to treat multiple sclerosis. The agency specifically pointed to glatiramer acetate, marketed under the brand names Copaxone and Glatopa, which have been associated with potentially fatal episodes of anaphylaxis. Glatiramer … Read more
Washington, D.C. – Health experts are warning patients and healthcare providers about the rare but potentially lethal risks of anaphylaxis linked to the use of the drugs Copaxone and Glatopa, commonly prescribed for multiple sclerosis. Anaphylaxis, a severe allergic reaction, demands immediate medical intervention and manifests through symptoms such as wheezing, skin rash, vomiting, and … Read more
Washington, D.C. – The U.S. Food and Drug Administration (FDA) has recently announced a major recall concerning the software used in Philips’ Mobile Cardiac Outpatient Telemetry (MCOT) devices, sparked by a critical failure in the system’s ability to alert healthcare professionals to severe heart-related events. This recall is classified as Class I, indicating that the … Read more
WASHINGTON — The Food and Drug Administration is currently probing a series of illnesses and now two deaths that may be connected to products from Diamond Shruumz, a company known for its “microdose” edibles. These products, which include chocolate bars, infused cones, and gummies, were all recently recalled following reports from consumers across 28 states. … Read more
Washington, D.C. — The Food and Drug Administration (FDA) is currently investigating a potential link between two deaths and products sold by Diamond Shruumz, a company that recently recalled its microdosing products. Alongside these tragic cases, the FDA has reported a worrying number of illnesses believed to be tied to the consumption of this brand’s … Read more
WASHINGTON — The Food and Drug Administration is actively investigating a series of illnesses and two fatalities possibly linked to products from Diamond Shruumz, a company known for its “microdose” consumables such as chocolate bars, infused cones, and gummies. This development follows a recall initiated by the company in June after reports of adverse effects … Read more
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