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The Latest Breaking News from FDA

Patients with Wounds That Will Not Close Get a Rare Say in How Treatments Are Tested

FDA is hearing directly from patients with nonhealing chronic wounds today, and written comments stay open to anyone until October 26.

Medical Daily · Aug 26

One Recalled Saline Ampule Set Off a Cascade of Kit Recalls Reaching Thousands of American Hospitals

FDA has posted a run of early alerts and recalls involving convenience kits, most tracing back to recalled drug ampules and syringes.

Medical Daily · Aug 26

Newborn Breathing Sets Are Being Pulled From Hospitals After Tubing Was Found Loosening From Nasal Cannulas

FDA issued an early alert on CooperSurgical INCA infant nasal CPAP sets after reports that the tubing can loosen and disconnect during use.

Medical Daily · Aug 26

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His Throat Carried Ten Times More Ebola Virus Than His Blood, and That Was Not Supposed to Happen

A Nature Medicine case report tracks a 39-year-old evacuated from Congo, treated with MBP134 and remdesivir, and discharged on day 22.

Medical Daily · Aug 25

Taking Melatonin Every Night? Sleep Experts Say There’s Something You Should Know

Melatonin has become the bedtime routine many people barely think about anymore: brush your teeth, plug in your phone, take a gummy, and turn out...

Saving Advice · Aug 25

Mark Cuban Says ‘No Chance’ Radiologists Get Replaced by AI — Medicine Is a Business and the Stakes Are ‘Life and Death’

Mark Cuban says AI won’t replace radiologists but will become essential to the job, creating a potential investment opportunity in AI-powered medical imaging and health care.

Barchart · Aug 25

Duchenne Cell Therapy Decision Slips to November After FDA Labels New Arm Function Data a Major Amendment

FDA pushed the deramiocel decision to November 22 after classifying Capricor's new 24-month HOPE-3 data as a major amendment to the filing.

Medical Daily · Aug 25

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Hunter Syndrome Gene Therapy Halted by FDA After Spine Scans Show Small Masses in Five Children

FDA placed REGENXBIO's RGX-121 on clinical hold after spine MRIs showed nodules or cysts in five Hunter syndrome trial participants.

Medical Daily · Aug 25

FDA Clears Roche Blood Test That Can Rule Alzheimer's Amyloid In or Out Without a Brain Scan

FDA cleared Roche's Elecsys pTau217 blood test for adults 55 and older with cognitive symptoms. What it can and cannot tell patients.

Medical Daily · Aug 25

Firefighters Union Warns Members Against Glutathione IV and Nebulizer Treatments Offered at Wildfire Camps This Summer

The IAFF warns wildland firefighters that glutathione given by IV or nebulizer is unproven, after two pharmacies recalled contaminated batches.

Medical Daily · Aug 25

Thyroid Tablets Pulled Nationwide After Testing Confirmed One Lot May Contain More Hormone Than the Label States

Vitruvius recalled a lot of Thyroid Tablets USP 30 mg nationwide due to potential super potency. Check lot 504950 and call your prescriber.

Medical Daily · Aug 25

A Pediatric Neurologist Who Testified for Vaccine Injury Claimants Now Runs the Federal Child Health Research Institute

NIH named Dr. John Gaitanis to lead its $1.7 billion child health institute. He has served as an expert witness for vaccine injury claimants.

Medical Daily · Aug 25

Estrogen Patch Supply Still Falls Short of Demand While the Product Stays Off the Federal Shortage List

Manufacturers say the supply of estrogen patches cannot meet demand, but the FDA has not listed estradiol patches as in shortage. Here is why that gap matters.

Medical Daily · Aug 25

Federal Regulators Publish Generic Development Roadmaps for Epinephrine, ADHD Stimulants and Levothyroxine as Comment Window Opens

The FDA published 48 draft generic development guidances covering epinephrine, ADHD stimulants, and levothyroxine, with public comments due October 23.

Medical Daily · Aug 25

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Medical Daily · Aug 25

Hospitalization Rate in the Jalapeño Salmonella Outbreak Climbs to 15 Percent as Resistance Appears in Three Samples

The hospitalization rate in the jalapeño Salmonella outbreak rose to 15 percent, and CDC sequencing now flags drug resistance in three patient samples.

Medical Daily · Aug 25

Eli Lilly Presses Payment Processors and Social Platforms as Federal Enforcement Struggles to Slow Retatrutide Sales

With FDA enforcement stalled at the warning-letter stage, Lilly is pressuring credit card companies and social media platforms to cut off retatrutide sellers.

Medical Daily · Aug 25

Sprout Distribution Map Confirms Only Two States as Illnesses Reach Fifteen and Two Mixed Cups Are Recalled

The FDA's product distribution map covers only Minnesota and Wisconsin, while sprout outbreak illnesses span 15 states. Two more products were named.

Medical Daily · Aug 25

The Public Comment Window on a Plan to Speed Experimental Drugs into Human Trials Closes Tonight

The FDA's Expedited IND pilot comment period ends at 11:59 p.m. ET on August 24. Here is what the proposal would and would not change.

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Medical Daily · Aug 25

An Amino Acid Dispute Between Eli Lilly and the FDA Could Delay Cheaper Retatrutide by Years

A federal court fight over whether retatrutide counts as a biologic will decide if patients wait 12 years or five for cheaper competition.

Medical Daily · Aug 24

FDA Decision Due Thursday on a Two-Drug HIV Pill Designed to Simplify Complex Daily Regimens

The FDA faces an August 27 target date on Gilead's bictegravir and lenacapavir tablet for adults already virally suppressed on HIV therapy.

Medical Daily · Aug 24

Wisconsin Pet Food Maker Recalls Nearly 5,800 Cases of Canned Dog Food Over Possible Metal Fragments

Fromm recalled two wet dog food varieties over possible metal contamination, nine days after a separate raw dog food recall for Salmonella.

Medical Daily · Aug 24

Second Texas Pharmacy in Two Weeks Recalls Glutathione Injection After Patients in 14 States Report Reactions

A Houston pharmacy recalled a glutathione injection lot sent to patients in 14 states after reports of fever, chills, and allergic reactions.

The Guardian - US · Aug 24

Alfalfa sprouts linked to food-poisoning outbreak in 15 states, US officials say

Everything Sprouts recalls products after CDC says agency is aware of dozens of food-poisoning cases nationally

Medical Daily · Aug 24

A Second Texas Pharmacy Recalls Compounded Glutathione Injections Across Fourteen States Over Elevated Bacterial Toxin Levels

Optimal Balance Pharmacy recalled a lot of compounded glutathione over elevated endotoxins, two weeks after a similar Texas recall.

Saving Advice · Aug 24

FDA Finalizes Rules for Deciding When Generic Drugs Can Substitute for Brand-Name Prescriptions

The U.S. Food and Drug Administration has finalized guidance explaining how it determines whether prescription drug products are therapeutically equivalent—an evaluation that can help pharmacists,...

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