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A photo of the Food and Drug Administration building in Silver Spring, Maryland., Dec. 10, 2020.

FDA Limits Toxic Lead in Some Baby Foods

Guidance could reduce lead exposure by about 20% to 30%

A photo of a healthcare worker using a pulse oximeter in Gauhati, India, Jan. 21, 2021.

FDA Unveils Draft Guidance to Improve Pulse Oximeter Accuracy Across Skin Tones

Agency recommends conducting larger studies with more patients from different racial groups

A computer rendering of CAR-T cells attacking cancer cells.

CAR-T Warning for Secondary Malignancies: Warranted or Not?

FDA boxed warning led to multiple studies on the issue in 2024

A photo of Daye hemp+cotton pads.

CBD-Coated Tampons? FDA Says No Way

Agency also warns about Daye's vaginal microbiome screening kit

A photo of Mehmet Oz, MD.

Will the Trump Administration Be a Dangerous Ally to the Wellness Industry?

Several nominees may pose a threat to evidence-based public health

A computed tomography angiography scan of the pulmonary arteries.

Have the New Pulmonary Hypertension Drugs Changed the Game?

Macitentan/tadalafil and sotatercept approvals shifted the field, but by how much seems to differ

A photo of a woman holding an injection pen.

GLP-1 Agents and Suicide: Making Sense of 2024's Mixed Data

Research should be interpreted cautiously, says researcher

A photo of the FDA headquarters building as seen behind FDA logos at a bus stop on the agency鈥檚 campus.

FDA Proposes New Testing Rules to Ensure Cosmetics Are Asbestos-Free

Proposal comes after years of lawsuits alleging links between talc-based baby powder and cancer

A photo of shoppers in a busy supermarket.

Eat, Drink, and Be Wary

What does the future hold in the wake of recent foodborne fiascos?

A photo of a person holding a decongestant pill containing phenylephrine.

FDA Says Decongestant in Many Cold Medicines Doesn't Work. So What Does?

A look at the agency's recent moves on a leading decongestant

FDA APPROVED Generic liraglutide (Victoza) over a photo of a man self-injecting diabetes medication.

First Generic of Once-Daily GLP-1 Injection Approved for Diabetes

Generic liraglutide approved at dosage for type 2 diabetes only

FDA APPROVED tirzepatide (Zepbound) over a photo of a sleep apnea mask.

FDA Approves First Sleep Apnea Drug

Tirzepatide ok'd for obstructive sleep apnea in people with obesity

FDA APPROVED Acellular tissue engineered vessel (Symvess) over a computer rendering of a bleeding artery.

FDA OKs Bioengineered Vessel to Reduce Limb Amputations After Vascular Trauma

Off-the-shelf product indicated for cases where autologous vein harvesting is not an option

FDA APPROVED olezarsen (Tryngolza) over a computer rendering of fats in the bloodstream.

First Drug Approved for Familial Chylomicronemia Syndrome

Antisense oligonucleotide olezarsen slashes high triglycerides

A photo of smoked salmon for sale in a grocery store.

White Bread Out, Salmon In: FDA Releases 'Healthy' Food Claim Rule

Final rule is first update to "healthy" nutrient content claim in 30 years

A photo of a Mounjaro injection pen sitting on a box of four.

FDA Says Compounded Tirzepatide Must Exit the Market

Compounders only have 2 to 3 months left to copy injectable

FDA APPROVED remestemcel-L (Ryoncil) over a photo of a bag of stem cells in a purple rubber-gloved hand.

FDA Approves Mesenchymal Stromal Cell Therapy for Refractory Acute GVHD in Kids

Response rate of 70% at day 28 with remestemcel-L

FDA APPROVED ensartinib (Ensacove) over a computer rendering of lung cancer.

New First-Line Option for Advanced ALK-Positive Lung Cancer

In randomized study, ensartinib doubled PFS versus first-generation ALK inhibitor

FDA WARNING fezolinetant (Veozah) over a photo of the product.

FDA Adds Boxed Warning to Hot Flash Drug

The warning highlights known risk of rare but serious liver injury associated with fezolinetant

FDA APPROVED tapinarof (Vtama) over a photo of atopic dermatitis on a man鈥檚 arm.

Nonsteroidal Topical OK'd for Atopic Dermatitis

FDA approves tapinarof cream 1% for adults and kids 2 years and up

FDA APPROVED crinecerfont (Crenessity) over a computer rendering of a transparent body with the adrenal glands highlighted.

FDA Approves First Drug for Classic Congenital Adrenal Hyperplasia in 70 Years

Crinecerfont reduces excessive adrenal androgen production, lowering glucocorticoid dose

FDA APPROVED cosibelimab (Unloxcyt) over a photo of cutaneous squamous cell carcinoma.

Cosibelimab OK'd for Cutaneous Squamous Cell Carcinoma

PD-L1 inhibitor indicated for metastatic or locally advanced disease

FDA APPROVED nemolizumab (Nemluvio) over a photo of atopic dermatitis.

FDA Approves New IL-31 Drug for Eczema

Nemolizumab indicated for chronic skin disease in adults and kids ages 12 years and up

The FDA Hasn't Inspected This Drug Factory After 7 Recalls for the Same Flaw

With a potentially deadly recall, case highlights shortcomings in overseas drug manufacturing

A computer rendering of antibodies attacking a COVID virus.

FDA Revokes EUAs of Four COVID-19 Monoclonal Antibodies

Mostly expired drugs are no longer effective against circulating SARS-CoV-2 strains

FDA ADCOMM RSV vaccine safety in pediatric populations over a computer rendering of RSV virus particles.

FDA Advisors Say More Data Needed for RSV Vaccines in Young Kids

A "very complicated situation" after mRNA vaccine trial was halted, expert says

Morning Break over illustration of a syringe, Covid virus, and DNA helix over a photo of green vegetation.

RFK Jr.'s Lawyer Asked FDA to Pull Polio Vaccine; Pollution-VTE Link; H5N1 in Cats

Health news and commentary gathered by 番茄社区app staff

FDA SAFETY obeticholic acid (Ocaliva) over a photo of the product over a computer rendering of the biliary tree.

FDA Issues Safety Alert on Liver Disease Drug

Obeticholic acid (Ocaliva) may cause serious liver damage even in PBC patients without cirrhosis

A photo of a female physician writing a prescription.

Providers, You Are the Missing Piece: Your Patients With OUD Need You

Resources and treatment are essential to addressing the overdose crisis

A screenshot of Bernie Sanders speaking during this hearing.

FDA Panned at Senate Hearing for Failure to Address Diabetes, Obesity Epidemics

Agency has failed to hold food manufacturers accountable, said Sen. Bernie Sanders

FDA APPROVED durvalumab (Imfinzi) over a computer rendering of lung cancer.

Durvalumab Wins FDA Approval in Limited-Stage SCLC

Unprecedented 22.5-month improvement in median overall survival as consolidation therapy

FDA APPROVED zenocutuzumab-zbco (Bizengri) over a computer rendering of monoclonal antibodies attacking cancer cells.

FDA OKs First Drug Targeting NRG1 Gene Fusion in Pancreatic, Lung Cancers

Zenocutuzumab achieved response rates of 40% in pancreatic adenocarcinoma, 33% in advanced NSCLC

A photo of the the Supreme Court building in Washington, Nov. 2, 2024.

Supreme Court Doesn't Seem Convinced FDA Was Unfair in Blocking Flavored Vapes

Companies say agency changed its standards with little warning as it blocked sale of new products

3-D rendering of Florida.

Florida's Canadian Drug Import Plan Goes Nowhere After FDA Approval

A year after being greenlit, the program has yet to begin

A photo of a woman holding her boy who suffers from adrenoleukodystrophy.

FDA Investigating Blood Cancer Risk With Gene Therapy Skysona

Agency is evaluating the need for further regulatory action

Image of the vegetable department of a grocery store.

Have Foodborne Illness Outbreaks Really Increased?

The answer may have more to do with how we track them, experts say

Attruby is an orally administered near-complete stabiliser of TTR.

Acoramidis Snags FDA Approval for ATTR Cardiomyopathy

Another pricey TTR stabilizer to hit shelves

Morning Break over illustration of a syringe, Covid virus, and DNA helix over a photo of green vegetation.

Dr. Oz's Dubious Claims; Bird Flu Found in Raw Milk; Whooping Cough Surges

Health news and commentary gathered by 番茄社区app staff

A computer rendering of a robot hand holding a sphere which contains a medical shield and cross.

Digital Doctors Are Coming. Regulators Need to Catch Up.

We must ensure AI advances in medicine in a way that's safe, fair, and beneficial for all

A photo of Marty Makary, MD, MPH.

Trump's FDA Pick Is 番茄社区app's Former Top Editor

Marty Makary has made a name for himself challenging the medical establishment

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