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The Latest Breaking News from FDA

Breaking Live 3 publishers covering this story in the last 6 hours

13m ago Common Horse Ivermectin Tubes Treat a 1,250-Pound Animal, and a 79-Year-Old Who Swallowed One Needed Two Bowel Surgeries
1h ago Olympus Capsule Endoscope Set and Small-Intestine Scope Join FDA Import Alert, but Hospitals Can Keep Using Current Devices
2h ago Before Paying Cash for Ozempic or Wegovy, Do the 12-Month Math
3h ago What a Knee MRI Shows That an X-Ray Cannot
5h ago Nearly Two in Three Eosinophilic Esophagitis Patients on Tezspire Reached Tissue Remission After One Year of Treatment

Fall vaccine guide: What to know about new flu, COVID, and RSV shots amid federal confusion

Leading U.S. medical groups are urging people to get updated flu and COVID-19 vaccinations this fall

The Independent UK · Sep 2

A Quarterly Injection Cut Acute Pancreatitis Attacks by 78 Percent in Adults with Dangerously High Triglycerides

Two Phase 3 trials of plozasiran cut triglycerides by about 80% and reduced acute pancreatitis events by 78%. An FDA filing is expected by year-end.

Medical Daily · Sep 2

The FDA Has Put Its Strongest Warning on a Common Iron Infusion Over Dangerously Low Phosphate

FDA added a boxed warning to Injectafer over symptomatic hypophosphatemia. Fewer than 20% of infusions include a blood test that would catch it.

Medical Daily · Sep 2

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A Seed Supplier Linked to a Fifteen State Sprout Outbreak Has Not Answered the FDA's Recall Request

FDA says the alfalfa seed supplier in a 15-state sprout outbreak has not answered its recall request and another grower used the same lot.

Medical Daily · Sep 2

Sleep Apnea Pill Faces a February Decision After Regulators Questioned Whether Its Main Result Is Meaningful

AD109 cut breathing interruptions 44% in a 646 person trial. The FDA set a February 28 decision date and has questioned the primary endpoint.

Medical Daily · Sep 2

Recalled Newborn Breathing Circuits Land in the FDA's Middle Risk Tier After Reports of Connectors Melting

The FDA classified the Medline neonatal breathing circuit recall as Class II. What the middle risk tier means for families with an infant on a ventilator.

Medical Daily · Sep 2

Abortion Pill Case Is Frozen Until December While a Federal Judge Waits for the FDA Review

A federal judge paused the Texas and Florida mifepristone lawsuit until December 1 or the end of the FDA safety study. Access is unchanged.

Medical Daily · Sep 2

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Federal Regulators Add Their Strongest Warning to a Common Iron Infusion Over Dangerously Low Phosphate Levels

The FDA added a boxed warning to Injectafer over dangerously low phosphate. What patients getting iron infusions should ask their clinician.

Medical Daily · Sep 2

Adding a Second Pill to Tagrisso Delayed Lung Cancer Progression in Newly Diagnosed Patients in China

A phase 3 trial in China found savolitinib plus osimertinib delayed progression in first-line MET-overexpressing EGFR-mutated lung cancer.

Medical Daily · Sep 2

Millions Take Zyrtec Daily, and Stopping After Months of Use Can Trigger Severe Itching in Rare Cases

Federal regulators require a warning about severe itching after stopping long-term cetirizine or levocetirizine. What allergy patients should know.

Medical Daily · Sep 2

Breast Ultrasound Kits Join a 16 Record Medline Recall Traced to Wrinkled Packaging on Sterile Skin Applicators

FDA classified a Medline recall covering ultrasound breast packs plus 15 other kit records over a possible sterile barrier breach.

Medical Daily · Sep 2

Cesarean and Delivery Prep Trays Are Among 13 Medline Kit Recalls Tied to Faulty Applicator Seals

FDA classified 13 Medline convenience kit recall records covering 222,653 units, including cesarean and labor and delivery prep trays.

Medical Daily · Sep 2

An Oral Pill for Relapsing MS Beat a Standard Drug in Two Trials with No Figures Released

Novartis says remibrutinib beat teriflunomide in two Phase 3 MS trials. The company released no numbers and the data are unpublished.

Medical Daily · Sep 2

One Lot of a Medication Used to Prevent Alcohol Relapse Failed a Dissolution Test in Nationwide Recall

A single lot of acamprosate was recalled after failing dissolution testing. Patients should check with a pharmacy without interrupting treatment.

Medical Daily · Sep 2

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Medical Daily · Sep 2

Black Spots on Seizure Pills Trigger a Nationwide Recall and the Wrong Reaction Could Be Dangerous

A nationwide recall covers 1,968 bottles of carbamazepine tablets with black spots. Stopping a seizure drug abruptly carries its own risks.

Medical Daily · Sep 2

Children as Young as Two with Ulcerative Colitis Can Now Get Stelara After an FDA Label Expansion

FDA cleared Stelara for pediatric ulcerative colitis in children 2 and older. Here is what the trial showed and what families should ask.

Medical Daily · Sep 2

Horizon Organic Recalls More Than 53,000 Cases of Shelf Stable Chocolate Milk with Best By Dates in 2027

Horizon recalled 53,760 cases of shelf-stable chocolate milk boxes. Best-by dates run into February 2027, so cartons may still be at home.

International Business Times UK · Sep 1

More Than 10,000 Cases of Tofu Recalled Across 29 States Over Possible Chemical Contamination From Ink

Hodo, Inc. recalls over 10,000 cases of its Chili Crisp Lightly Fried Tofu due to ink contamination concerns, affecting distribution across 29 states. No illnesses reported, but consumers advised to discard affected products.

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The Economic Times · Sep 1

Science says microwaves don’t really cook food from the inside out, here’s what happens inside the oven

Microwaves bounce off the metal walls inside the oven, and when the reflected waves interact with incoming waves, they can create areas of stronger and weaker electromagnetic fields. These nodes and antinodes produce regions where food absorbs different amounts of microwave energy. This uneven distribution is also why many traditional…

Medical Daily · Sep 1

People with the Most of This Sugar Substitute in Their Blood Had More Heart Attacks and Strokes

New data presented in Munich link high blood xylitol levels to more cardiovascular events across two cohorts. The finding is an association, not proof.

Medical Daily · Sep 1

A Cincinnati Olive Oil Sold for Nearly a Year Used a Garlic Oil Never Cleared for Food

A Cincinnati garlic-infused olive oil sold for nearly a year used an essential oil not approved for culinary use. No illnesses were reported.

The Economic Times · Sep 1

Maharashtra FDA suspends Blinkit, 2 Mumbai eateries’ food licences over serious hygiene violations

In a significant regulatory move, the Maharashtra FDA has suspended food licenses for a Blinkit center and two popular Mumbai restaurants after uncovering critical hygiene and safety failings. Inspections revealed food stored dangerously close to drains and a concerning presence of cockroaches. Furthermore, officials identified uncertified food handlers and visible…

Medical Daily · Sep 1

A New Weekly Injection Cut Repeat Blood Draws for Most Patients with a Rare Blood Cancer

FDA approved Mimrylo for polycythemia vera. In trial data, 76.9% of patients needed no blood draws during weeks 20 to 32, versus 32.9% on placebo.

Medical Daily · Sep 1

A Second Sprout Product Joins the Outbreak Recall and the Newest Lots Shipped Only Days Ago

A radish sprout mix has been added to the multistate sprout outbreak recall. Lots shipped through late August may still be in refrigerators.

Medical Daily · Sep 1

Halloween Chocolate Sold at TJ Maxx and Marshalls in Thirteen States Is Recalled Over Hidden Milk

Chocolatey Eyeballs sold at TJ Maxx, Marshalls, HomeGoods, and Sierra in 13 states contain undeclared milk. No refunds at the register.

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