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

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

Dec 19, 2024
A photo of smoked salmon for sale in a grocery store.
FDA Says Compounded Tirzepatide Must Exit the Market

Compounders only have 2 to 3 months left to copy injectable

Dec 19, 2024
A photo of a Mounjaro injection pen sitting on a box of four.
FDA Approves Mesenchymal Stromal Cell Therapy for Refractory Acute GVHD in Kids

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

Dec 19, 2024
FDA APPROVED remestemcel-L (Ryoncil) over a photo of a bag of stem cells in a purple rubber-gloved hand.
New First-Line Option for Advanced ALK-Positive Lung Cancer

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

Dec 18, 2024
FDA APPROVED ensartinib (Ensacove) over a computer rendering of lung cancer.
FDA Adds Boxed Warning to Hot Flash Drug

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

Dec 17, 2024
FDA WARNING fezolinetant (Veozah) over a photo of the product.
Nonsteroidal Topical OK'd for Atopic Dermatitis

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

Dec 17, 2024
FDA APPROVED tapinarof (Vtama) over a photo of atopic dermatitis on a man’s arm.
FDA Approves First Drug for Classic Congenital Adrenal Hyperplasia in 70 Years

Crinecerfont reduces excessive adrenal androgen production, lowering glucocorticoid dose

Dec 16, 2024
FDA APPROVED crinecerfont (Crenessity) over a computer rendering of a transparent body with the adrenal glands highlighted.
Cosibelimab OK'd for Cutaneous Squamous Cell Carcinoma

PD-L1 inhibitor indicated for metastatic or locally advanced disease

Dec 16, 2024
FDA APPROVED cosibelimab (Unloxcyt) over a photo of cutaneous squamous cell carcinoma.
FDA Approves New IL-31 Drug for Eczema

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

Dec 16, 2024
FDA APPROVED nemolizumab (Nemluvio) over a photo of atopic dermatitis.
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

Dec 15, 2024
A photo of the Glenmark logo on a facility occupied by Glenmark Pharmaceuticals in Mahwah, New Jersey.
FDA Revokes EUAs of Four COVID-19 Monoclonal Antibodies

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

Dec 13, 2024
A computer rendering of antibodies attacking a COVID virus.
FDA Advisors Say More Data Needed for RSV Vaccines in Young Kids

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

Dec 13, 2024
FDA ADCOMM RSV vaccine safety in pediatric populations over a computer rendering of RSV virus particles.
RFK Jr.'s Lawyer Asked FDA to Pull Polio Vaccine; Pollution-VTE Link; H5N1 in Cats

Health news and commentary gathered by 51˶ staff

Dec 13, 2024
Morning Break over illustration of a syringe, Covid virus, and DNA helix over a photo of green vegetation.
FDA Issues Safety Alert on Liver Disease Drug

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

Dec 12, 2024
FDA SAFETY obeticholic acid (Ocaliva) over a photo of the product over a computer rendering of the biliary tree.
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