FDA investigating risk of acute liver failure with Sarepta gene therapies
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Newsweek
an hour ago
- Newsweek
FDA Issues Bread Recall Update After Glass Discovered in Crusts
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. The U.S. Food and Drug Administration (FDA) has ended a voluntary recall of 800 items after glass fragments were discovered in the crusts of several breads. Maryland-based Upper Crust Bakery LP initiated the recall regarding products distributed to six states: Pennsylvania, California, Connecticut, Maryland, Delaware, and Ohio. Upper Crust Bakery LP, operating out of Glenn Dale, voluntarily recalled three varieties of bread—Ancient Grains Hoagie Roll, Multigrain Sourdough, and Whole Grain Multigrain—after a team member discovered a glass fragment on a piece of seeded bread. The recall initially began on April 12, 2025, and the FDA classified it as Class II on April 25, the second-highest of three risk levels, which indicates the potential for temporary or reversible health consequences. The FDA terminated the recall on July 15. Stock image of sourdough bread slices. Stock image of sourdough bread slices. Getty Images Why it Matters The FDA warned that consuming glass fragments could cause injuries ranging from cuts in the mouth and throat to intestinal perforation—a risk prompting significant public attention. What To Know According to FDA records, the recall covered three products: Ancient Grains Hoagie Roll , 4 oz, Lot #90, 89 cases, carton code CP45, distributed frozen , 4 oz, Lot #90, 89 cases, carton code CP45, distributed frozen Multigrain Sourdough , 18 oz, Lot #90, 699 cases, carton code CP12, distributed frozen , 18 oz, Lot #90, 699 cases, carton code CP12, distributed frozen Whole Grain Multigrain, 20 oz, Lot #92, 30 cases, carton code CP12, distributed frozen The bakery, operating as Crest Hill Bakery, notified the FDA after an employee discovered a glass fragment during a routine inspection. Further investigation traced the source of the glass to sunflower seeds provided by supplier Magic Flame. Upper Crust Bakery LP stated that it immediately ceased using ingredients from the implicated supplier and removed all affected products from circulation. "We have ceased the use of sunflower seeds from the manufacturer associated with the glass fragments, Magic Flame," the company said in a statement announcing the recall. For consumers, the FDA and Upper Crust Bakery LP advised that bread with affected lot numbers should not be consumed but instead discarded or returned to the point of purchase for a refund. Health experts emphasized contacting a health care provider if glass ingestion is suspected due to the risk of gastrointestinal injury. Who People Are Saying Upper Crust Bakery LP, in a statement announcing the recall: "The recall was initiated after a vigilant team member discovered a small glass fragment on top of a piece of seeded bread." "We remain steadfast in our commitment to upholding the highest standards of quality and safety in all our products," the company added. The FDA warned at the time: "The agency warns that consuming glass fragments can result in significant injuries such as damage to teeth, lacerations of the mouth and throat, or perforation of the intestine." What Happens Next With the recall terminated as of July 15, 2025, Upper Crust Bakery LP stated that it has stopped sourcing sunflower seeds from the implicated supplier and has amended its food safety checks. For further updates on food recalls and safety guidance, visit the FDA's official recall search portal.
USA Today
an hour ago
- USA Today
Ice cream bars sold in 23 states recalled over listeria risk
More than 100,000 ice cream bars produced by Rich's Ice Cream have been recalled over concerns of potential listeria contamination. The Food and Drug Administration Authority (FDA) announced July 17 that Florida-based Rich's Ice Cream Co. is recalling select products due to potential listeria monocytogenes contamination. The recall, which impacts lot number 24351 through lot 25156 was initiated on June 27, according to the FDA notice and is classified as Class II with a total of 110,292 cases potentially affected. A Class II recall is "a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote," the FDA website states. USA TODAY was unable to reach Rich's Ice Cream for comment on July 21. Which Rich Ice Cream products are included in the recall? See list The affected products, sold in multiple states, according to the FDA advisory, include: The frozen treats were individually packaged in plastic bags and sold in master cases. More recalls: Ford, Mercedes-Benz, Jaguar among over 738,000 vehicles recalled: Check car recalls Which states are impacted by the recall? See list The affected products were distributed across 23 states, according to the FDA notice, including: They were also sold in Nassau, the capital of The Bahamas. What should you do if you purchased the affected products? FDA and Rich Ice Cream Co. have not yet specified what remedies are available for customers. Rich Ice Cream Co. did not immediately reply to USA TODAY's request for a statement and more information on the recall. Customers, meanwhile, can visit Rich Ice Cream Co.'s website for more information and to contact the company. Listeria poisoning symptoms Listeriosis, or listeria poisoning, is a foodborne bacterial infection most commonly caused by the bacterium listeria monocytogenes, according to the Centers for Disease Control and Prevention. It is considered a serious condition and can be dangerous or life-threatening, especially to older adults, people with weak immune systems, and pregnant women. Listeria is the third leading cause of death from foodborne illness in the U.S., according to the CDC. The agency estimates that the disease impacts 1,600 Americans each year, with approximately 260 people dying from those infections. Symptoms include, per the CDC: People in higher-risk categories who experience flu-like symptoms within two months after eating contaminated food should seek medical care. Contributing: Natalie Neysa Alund, USA TODAY Saman Shafiq is a trending news reporter for USA TODAY. Reach her at sshafiq@ and follow her on X and Instagram @saman_shafiq7.
Los Angeles Times
2 hours ago
- Los Angeles Times
FDA Appoints Biotech Executive as Top Drug Regulator Under RFK Jr.
Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency's top drug regulator, the agency confirmed Monday. Tidmarsh, an adjunct professor of pediatrics and neonatology at Stanford University, will serve as director of the Center for Drug Evaluation and Research, one of the FDA's largest and most important divisions with a staff of about 5,700 that reviews the vast majority of new drug applications. Jacqueline Corrigan-Curay, the acting head of the CDER, recently announced she was leaving the agency. Tidmarsh, 65, was involved in the development of several approved drugs, likely making him a reassuring choice for a pharmaceutical industry that's facing pressure from the Trump administration to lower prices and move manufacturing to the US. Tidmarsh's appointment 'brings in a generally well-respected, credible industry veteran, we believe helping fill a key regulatory void,' Brian Abrahams, an analyst at RBC Capital Markets, said in a note to clients. While recent cuts at the agency have raised concerns about the FDA's drug approval process, 'we would expect Tidmarsh to be a pragmatic officer who will likely build upon current practice to ensure continuity and potentially be an advocate for the industry.' Among the controversies Tidmarsh will contend with is the agency's accelerated approval process. The use of this expedited pathway to get drugs green lit has skyrocketed in recent years and been criticized for sometimes letting unproven treatments linger on the market for too long. Advocates say speeding up the process gets drugs quickly to patients suffering from serious diseases. Tidmarsh is also primed to be a key player in reassessing the agency's approach to regulating prescription drug advertising. Health Secretary Robert F. Kennedy Jr. has long been a critic of direct-to-consumer drug advertising, and Makary has indicated that the agency is reviewing its approach to regulating such ads. During a panel on censorship and scientific speech at Stanford last year, Tidmarsh raised concerns about the FDA's inconsistent regulation of pharmaceutical products. He pointed to the agency's long-standing restrictions on off-label communication by manufacturers and questioned some vaccine makers' ads during the pandemic.'This discrepancy shows that FDA may apply free speech regulation at a whim and inconsistently,' he said. While the FDA's vaccine division has been in the spotlight recently over Covid shots, the drug division has made some of the agency's most controversial decisions. In the '90s, CDER approved language allowing opioid drugs, such as OxyContin, to be widely marketed — despite a lack of substantial evidence supporting their long-term effectiveness. The move helped pave the way for the opioid epidemic. The division also caused a firestorm after approving the Alzheimer's treatment Aduhelm that hadn't clearly been proven to work in research studies. On a recent podcast, Tidmarsh said he met Makary at a conference last fall at Stanford. It featured many people critical of restrictions and mandates during the pandemic, several of whom now have top government health jobs. Tidmarsh appears to share Makary's concerns about a lack of dissenting viewpoints in science. In a podcast about a year ago, he said academics foster a culture that is reluctant to question prevailing views and that grantmaking has become concentrated into a few hands. On LinkedIn last year, Tidmarsh wrote that 'academic science has become riddled with fraud, the time has come to root out the corruption.' He funds the Sleuth in Residence program that supports scientific fraud investigators at the website Retraction Watch, which tracks academic journals. At Stanford, Tidmarsh got both his medical degree and a PhD in cancer biology and then worked in the school's clinical faculty. He also had a series of biotech jobs, including chief executive officer for La Jolla Pharmaceutical Co., which developed a drug to treat sepsis and is now part of Innoviva Inc. Tidmarsh, who was also trained in pediatric oncology, has worked over the years to find solutions to shortages of old lifesaving cancer drugs. In an interview last year with a publication for doctors, he likened the US generic drug market to a 'wild west' where predatory contracting practices can drive out manufacturers. Langreth and Hornblower write for Bloomberg.
