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FDA General

FDA APPROVED valbenazine (Ingrezza) over a computer rendering of healthy brain and a brain in Huntington鈥檚 disease

Huntington's Disease Chorea Gets New Treatment

Thumbs up for the VMAT2 inhibitor valbenazine, FDA says

FDA ADCOMM Renal denervation for hypertension over a photo of a blood pressure monitor.

FDA Advisors' Recommendation on Renal Denervation Hinges on Effectiveness Question

Device-based hypertension treatments have only modest BP reductions

FDA APPROVED pozelimab (Veopoz) over a micrograph of the intestinal tissue of a child with CHAPLE disease.

Ultra-Rare Immune System Disease Gets First FDA-Approved Treatment

Pozelimab reduced hospitalizations, albumin transfusions in CHAPLE disease patients

FDA APPROVED Revi neuromodulation system over a photo of the device.

FDA Grants De Novo Request for Neuromodulatory System for Urge Incontinence

Three-fourths of patients had 50% reduction in incontinence at 6 months, 82% at 12 months

A photo of bagged spinach and lettuce in a grocery store produce section.

From Salad Roulette to Salmonella in Poultry and Peanuts

The folly of believing U.S. food is as safe as safe can be

FDA APPROVED palovarotene (Sohonos) over a photo of a skeleton of a fibrodysplasia ossificans progressiva sufferer.

First Therapy Approved for Ultra-Rare Bone Disorder

Oral retinoid lands indication for fibrodysplasia ossificans progressiva

FDA APPROVED melphalan/Hepatic Delivery System (Hepzato Kit) over a CT scan of liver metastasis

FDA OKs First Liver-Directed Treatment for Metastatic Uveal Melanoma

Hepzato Kit melphalan delivery system produced objective responses in 36% of patients

Kratom powder in homemade pill form.

Does Kratom Need Tighter Regulation?

Efforts to regulate or ban the drug have fizzled, leaving it in purgatory

FDA APPROVED avacincaptad pegol (Izervay) over a photo of age-related macular degeneration.

Second Drug for Geographic Atrophy Gets Green Light From FDA

Avacincaptad pegol reduced the rate of disease progression by as much as 35% after 12 months

FDA approved zuranolone (Zurzuvae) over a photo of a tired-looking woman sitting on the couch next to a baby stroller.

FDA OKs First Pill for Postpartum Depression

In one trial, more than twice as many women achieved remission after 2-week treatment course

A photo of the signage on the United States Patent and Trademark Office in San Jose, California

Continuation Patents Have Surged, Disrupting Generic Competition, Study Shows

Researchers caution that abusing patent laws harms patients, stifles innovation

ASRS over a photo of The Washington State Convention and Trade Center, in Seattle, Washington.

Sticker Shock: Ophthalmic Bevacizumab Biosimilar Could Drive Up Costs

Medicare expenditures could jump 15-30%, with similar increases in patients' out-of-pocket costs

FDA APPROVED dostarlimab (Jemperli) over a medical illustration of endometrial cancer.

FDA Approves New Frontline Endometrial Cancer Regimen, First in Decades

Dostarlimab (Jemperli) approved with chemotherapy for dMMR or MSI-high cancers

A photo of Robert Califf, MD

FDA Head Robert Califf Battles Misinformation 鈥� Sometimes With Fuzzy Facts

Often, the misinformation is about misinformation

A computer rendering of the implantation of the Impella 5.5 blood pump.

Impella Devices Recalled After Deaths, Injuries Tied to TAVR Interactions

Recall involves new instructions for use without devices needing to be returned

A photo of a technician lowering a section of umbilical cord into a vial.

FDA Warns Company Over Amniotic Products

Agency says Cell Genuity products should be regulated as a drug

FDA APPROVED lotilaner ophthalmic solution (XDEMVY) over a computer rendering of mites on eyelashes.

First Treatment for Demodex Blepharitis Wins FDA Approval

Lotilaner ophthalmic solution reduced eyelash collarettes, increased mite eradication

A photo of a female healthcare worker holding a large syringe.

DOJ Goes After PA for Amniotic Fluid Injections

Prosecutors called shots a "dubious attempt at pain management"

FDA APPROVED topical cantharidin (Ycanth) over a photo of a man鈥檚 skin affected by molluscum contagiosum

First Treatment Approved for Molluscum Contagiosum

Half of patients across two randomized trials had complete clearance of lesions

A photo of a vial of cord tissue.

FDA Strikes at Yet Another Birth Tissue Company

Agency sent warning letter to Regenative Labs over its Wharton's jelly product

FDA APPROVED nirsevimab (Beyfortus) over a computer rendering of respiratory syncytial viruses

New Drug Approved for Preventing RSV in Newborns, Tots

Nirsevimab indicated for all infants, and for kids up to 2 years at high risk

FDA APPROVED norgestrel (Opill) over a photo of the product.

First OTC Birth Control Pill Approved

Sea change for pregnancy prevention

A photo of the vial and packaging of Leqembi.

Registry Enrollment for Alzheimer's Drug Coverage Won't Help Much

A minimalist policy for a minimalist treatment

A photo of the Great Room in FDA building 31.

FDA Appears to Mostly Follow Its Drug Advisory Committees' Advice

"Pro-approval bias" suggests committees are used to identify barriers to approval, expert argues

FDA APPROVED lecanemab (Leqembi) over a computer rendering of amyloid plaque on nerve cells.

Alzheimer's Drug Wins Full FDA Approval

Decision expands lecanemab's Medicare coverage

Psychedelic Research: Experts React to FDA Draft Guidance

Feedback is mostly positive, but concerns arise around two-monitor recommendation

FDA APPROVED Aveir DR dual chamber leadless pacemaker over a photo of the device.

First Dual-Chamber Leadless Pacemaker Approved by FDA

System comprises two small leadless pacemakers communicating wirelessly

FDA APPROVED donislecel (Lantidra) over a photo of hypoglycemic woman testing her blood sugar with a glucose meter.

First Cellular Therapy Approved for Type 1 Diabetes

Infusion made from deceased donor pancreatic islet cells

FDA APPROVED rozanolixizumab-noli (RYSTIGGO) over a photo of a man with ptosis.

FDA Greenlights New Myasthenia Gravis Drug

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

FDA ADCOMM palovarotene over a photo of a skeleton of a person who suffered from fibrodysplasia ossificans progressiva

FDA Staff Weighs 'Alternative' Data on Retinoid for Rare Bone Disorder

Challenges of drug development in fibrodysplasia ossificans progressiva on full display

A photo of a senior man taking a cognitive test.

Without Early Detection, Fighting Dementia Is an Uphill Battle

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

FDA Approved inhibitor ritlecitinib (Litfulo) over a photo of a young woman suffering from alopecia areata.

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

A photo of the vials and packaging Leqembi for injection.

Our Health Systems Aren't Ready for the Full Approval of Lecanemab

Screening, administration, and eligibility concerns remain

FDA Approved delandistrogene moxeparvovec (Elevidys) over a photo of a female physical therapist helping a little boy walk.

Controversial Gene Therapy Wins FDA Approval for Duchenne Muscular Dystrophy

Sarepta's treatment gets a nod for ambulatory pediatric patients

A photo of Warrior Labz SARMS products.

Another Online SARMs Retailer Gets a Warning From the FDA

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

FDA APPROVED empagliflozin (Jardiance), metformin hydrochloride (Synjardy) over a photo of a boy checking his blood sugar.

First SGLT2 Inhibitor Approved for Kids With Type 2 Diabetes

Now another oral option other than metformin

FDA APPROVED colchicine (Lodoco) over a photo of a section of an artery narrowed from atherosclerosis.

Colchicine's Rebirth as Cardiovascular Drug Approved by FDA

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

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

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

FDA ADCOMM lecanemab over a computer rendering of an antibody bound to an amyloid beta peptide.

Alzheimer's Drug Clears Major Hurdle Toward Full Approval

But risks associated with anti-amyloid agent lecanemab still loom

A close up photo of a man holding a box of Paxlovid.

Did FDA Apply Rigorous Standards in Approving Paxlovid?

Evidence for all relevant studies should be accessible

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