FDA
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FDA Approves Fayuvi Gene Therapy for Sanfilippo Syndrome Following Family-Led Funding Effort
The FDA has approved Fayuvi, a gene therapy for Sanfilippo syndrome, marking a milestone for research sustained by family-led crowdfunding efforts.
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FDA Expands Enforcement Across Pharmaceuticals and Consumer Goods
The FDA issued Class II recalls for thousands of blood pressure pills and millions of pounds of sugar due to dissolution and contamination risks.
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Bacterial Contamination Probe Prompts Recall of Two Popular Canine Health Products
Fi has issued a recall for two dog supplement formulations after an ingredient supplier triggered potential Salmonella contamination risks.
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FDA Approves Eli Lilly’s Mounjaro to Reduce Cardiovascular Risk in Type 2 Diabetes Patients
The FDA has approved Mounjaro to reduce the risk of heart attack, stroke, or cardiovascular death in high-risk adults living with type 2 diabetes.
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Federal Regulators Raise Severity Level on Frozen Berry Recall Amid Conflicting Public Advisories
Federal regulators designated a massive frozen blueberry recall as Class I, while official portals display outdated lot information for consumers.
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Texas Grocer H-E-B Pulls Salata Dressing Following Multi-Retailer Jalapeño Salmonella Risk
H-E-B has recalled Salata brand jalapeño avocado dressing following warnings that supplier ingredients may be contaminated with Salmonella.
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FDA Elevates Egg Recall to Class I Following Salmonella Outbreak
The FDA has elevated the recall of nearly 19 million eggs to Class I status, signaling a serious health risk linked to a multi-state Salmonella outbreak.
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FDA Approves First mRNA Flu Vaccine for Adults 50 and Older
The FDA has approved Moderna’s mFlusiva, an mRNA-based flu vaccine for adults 50 and older, offering a faster production timeline and higher efficacy in trials.
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FDA Approves Moderna’s mRNA-Based Flu Vaccine for Older Adults
The FDA has approved mFlusiva, Moderna’s mRNA-based flu vaccine for adults 50 and older, offering a new tool to combat seasonal influenza.
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FDA Approves Moderna’s mRNA Flu Vaccine mFlusiva for Adults 50 and Older
The FDA has approved mFlusiva, the first mRNA-based influenza vaccine, for adults aged 50 and older, marking a major shift in vaccine technology.
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Capricor Therapeutics Faces Class Action Investigation After FDA Data Concerns Trigger 64% Stock Collapse
Rosen Law Firm has launched an investigation into Capricor Therapeutics following a 64% stock plunge triggered by FDA staff concerns over its DMD therapy, deramiocel.
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U.S. Health Officials Scramble to Identify Source of Record-Breaking Cyclospora Outbreak
As U.S. cases of Cyclospora exceed 4,000, officials investigate contaminated produce, highlighting major gaps in federal food safety and water testing rules.
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Federal Health Officials Investigate Concurrent Cyclospora Outbreaks
Federal agencies are investigating multiple concurrent Cyclospora outbreaks, including one linked to Taylor Farms lettuce and a new, unidentified source.
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FDA Reviews Safety of Synthetic Peptides Amid Growing Wellness Trend
The FDA is reviewing seven popular synthetic peptides to address safety risks as wellness trends outpace clinical data, threatening consumer health and safety.
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FDA Approves Lipfendra, First Oral PCSK9 Inhibitor for Cholesterol
The FDA has approved Lipfendra, the first daily oral PCSK9 inhibitor, offering a new treatment option for patients who require additional LDL cholesterol reduction.