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

Generic liraglutide approved at dosage for type 2 diabetes only

Dec 23, 2024
FDA APPROVED Generic liraglutide (Victoza) over a photo of a man self-injecting diabetes medication.
FDA Approves First Sleep Apnea Drug

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

Dec 20, 2024
FDA APPROVED tirzepatide (Zepbound) over a photo of a sleep apnea mask.
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

Dec 20, 2024
FDA APPROVED Acellular tissue engineered vessel (Symvess) over a computer rendering of a bleeding artery.
First Drug Approved for Familial Chylomicronemia Syndrome

Antisense oligonucleotide olezarsen slashes high triglycerides

Dec 20, 2024
FDA APPROVED olezarsen (Tryngolza) over a computer rendering of fats in the bloodstream.
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.
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