#FDA
articles
Appeals Court Backs Gilead in Ruling Threatening Overseas Drug Import Programs
A federal appeals court has found that international versions of Gilead's HIV drug Biktarvy are materially different fro...
FDA Upgrades Salmonella Egg Recall to Class I, Its Highest Risk Level
Nearly 1.6 million dozen eggs are under the FDA’s highest-risk classification after a salmonella outbreak sickened 98 pe...
FDA Approves Pluvicto for Hormone-Sensitive Metastatic Prostate Cancer
The targeted radiation drug can now be used with hormone therapy in PSMA-positive metastatic prostate cancer after trial...
Trump's MMR Unbundling Order Would Mean Six Doctor Visits, New Vaccine Plants—and Little Legal Force
The executive order asks for separate measles, mumps and rubella shots within 90 days, but no standalone vaccines exist ...
FDA Approves First CELMoD Drug Iberdomide for Relapsed Multiple Myeloma
Bristol Myers Squibb's oral iberdomide, paired with daratumumab and dexamethasone, becomes the first CELMoD approved for...
FDA's Mandatory GRAS Notification Rule Gets Cautious Industry Backing
Food and feed groups welcome the proposed GRAS transparency overhaul but warn that FDA resources, workable timelines and...
What the 'Wolverine' Peptide Stack Is — and Why Its Safety Remains Unverified
BPC-157 and TB-500 are being marketed as a regenerative 'Wolverine stack,' but neither has completed human clinical tria...
HHS Proposes Mandatory GRAS Notifications and First Federal Ultra-Processed Food Definition
HHS and FDA move to end self-certified GRAS ingredients and, with USDA, propose the first federal definition of ultra-pr...
A Patient's Guide to GLP-1 Side Effects: From GI Upset to Rare Eye Risks
GLP-1 drugs are widely prescribed, but patients should understand the range of reported side effects — from common nause...
Kennedy’s FDA Mandates GRAS Notifications and Proposes First Federal ‘Ultra-Processed’ Definition
HHS Secretary Robert F. Kennedy Jr. announced mandatory FDA notification for self-determined food ingredient safety and ...
FDA Moves to Mandate GRAS Notifications and Define Ultraprocessed Foods
The FDA proposed a rule requiring food companies to notify the agency when they deem an additive safe, while sending a w...
FDA Clears AI Coronary Inflammation Tool; Hofstra Sued Over Bar-Exam Cardiac Arrest
Caristo's CaRi-Heart wins FDA de novo clearance, Hofstra faces a cardiac-arrest lawsuit over bar-exam emergency care, an...
ADA Review, Retatrutide Access and GLP-1 Generics Lead a Busy Diabetes Week
A busy week for diabetes and obesity drugs: ADA reviews a police incident, Lilly expands retatrutide access, Novo faces ...
FDA Approves SimpleScreen: A Second Blood Test Aims to Close Colorectal Cancer Screening Gap
The FDA has cleared Freenome's SimpleScreen CRC test, giving U.S. adults a second blood-based option for colorectal canc...
HHS Moves to End Self-Affirmed GRAS Pathway for Food Ingredients
HHS directs the FDA to explore rulemaking that would require companies to notify the agency before introducing new ingre...
Skincare CEO Pleads Guilty to Selling Unapproved Injectable Products
The head of Arizona-based Scalpa Inc. admitted to three counts over unapproved injectable skincare products and agreed t...
Publix Recalls All GreenWise Frozen Blueberries as E. coli Cases Hit 12
Publix pulled all GreenWise organic frozen blueberry and mixed berry products from eight states after the FDA linked the...
Taco Bell Traffic Plummets as Cyclospora Outbreak Hits US Lettuce Sales
A cyclosporiasis outbreak traced to Taylor Farms iceberg lettuce from Mexico is driving double-digit drops in restaurant...
Cyclospora Outbreak Sickens Thousands as US Officials Hunt Elusive Contamination Source
A widespread Cyclospora intestinal parasite outbreak has left thousands ill across the United States, with investigators...
Taylor Farms Slow-Walked Recall, Fueled Confusion in Major Cyclospora Outbreak
Internal emails and official accounts reveal how Taylor Farms missed deadlines, leveraged White House ties, and issued c...