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FDA General

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First Cellular Therapy Approved for Type 1 Diabetes

Infusion made from deceased donor pancreatic islet cells

Jun 29, 2023
FDA APPROVED donislecel (Lantidra) over a photo of hypoglycemic woman testing her blood sugar with a glucose meter.
FDA Panel Backs Palovarotene for Ultra-Rare Bone Disorder

Members push aside data concerns, endorse retinoid for fibrodysplasia ossificans progressiva

Jun 29, 2023
FDA ADCOMM palovarotene over a photo of a skeleton of a person who suffered from fibrodysplasia ossificans progressiva
FDA Greenlights New Myasthenia Gravis Drug

First therapy approved for anti-AChR-positive and anti-MuSK antibody-positive patients

Jun 27, 2023
FDA APPROVED rozanolixizumab-noli (RYSTIGGO) over a photo of a man with ptosis.
FDA Staff Weighs 'Alternative' Data on Retinoid for Rare Bone Disorder

Challenges of drug development in fibrodysplasia ossificans progressiva on full display

Jun 27, 2023
FDA ADCOMM palovarotene over a photo of a skeleton of a person who suffered from fibrodysplasia ossificans progressiva
Opinion
Without Early Detection, Fighting Dementia Is an Uphill Battle

A brief assessment in primary care can help identify patients most at risk

Jun 27, 2023
A photo of a senior man taking a cognitive test.
First Oral JAK Inhibitor Approved for Severe Alopecia Areata in Teens

Ritlecitinib led to 80% scalp coverage at 6 months in nearly a fourth of adolescents and adults

Jun 26, 2023
FDA Approved inhibitor ritlecitinib (Litfulo) over a photo of a young woman suffering from alopecia areata.
Malaria Case in Texas; FDA Lays Path for Psychedelic Trials; Incels' Mental Health

Health news and commentary from around the Web gathered by MedPage Today staff

Jun 26, 2023
Morning Break over illustration of a syringe, Covid virus, and DNA helix over a photo of green vegetation.
Opinion
Our Health Systems Aren't Ready for the Full Approval of Lecanemab

Screening, administration, and eligibility concerns remain

Jun 23, 2023
A photo of the vials and packaging Leqembi for injection.
Controversial Gene Therapy Wins FDA Approval for Duchenne Muscular Dystrophy

Sarepta's treatment gets a nod for ambulatory pediatric patients

Jun 22, 2023
FDA Approved delandistrogene moxeparvovec (Elevidys) over a photo of a female physical therapist helping a little boy walk.
Another Online SARMs Retailer Gets a Warning From the FDA

Warrior Labz SARMS markets several drugs they claim could address weight loss, muscle growth

Jun 22, 2023
A photo of Warrior Labz SARMS products.
New Long COVID Guide; Transgender Patient Data Turned Over; Lab Grown Meat for Sale

Health news and commentary from around the Web gathered by MedPage Today staff

Jun 22, 2023
Morning Break over illustration of a syringe, Covid virus, and DNA helix over a photo of green vegetation.
First SGLT2 Inhibitor Approved for Kids With Type 2 Diabetes

Now another oral option other than metformin

Jun 21, 2023
FDA APPROVED empagliflozin (Jardiance), metformin hydrochloride (Synjardy) over a photo of a boy checking his blood sugar.
Colchicine's Rebirth as Cardiovascular Drug Approved by FDA

Repurposed anti-inflammatory drug may be used alone or in combination with standard meds

Jun 20, 2023
FDA APPROVED colchicine (Lodoco) over a photo of a section of an artery narrowed from atherosclerosis.
New Bispecific Antibody Approved for Tough-to-Treat Lymphoma

Approval of glofitamab was based on a phase I/II study that showed a 56% overall response rate

Jun 16, 2023
FDA APPROVED glofitamab (Columvi) over a computer rendering of antibodies attacking cancer cells.
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