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FDA General

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Psychedelic Research: Experts React to FDA Draft Guidance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

FDA ADCOMM nirsevimab over a computer rendered cutaway of an RSV virus.

Antibody for Infant RSV Prevention to Face FDA Panel

Nirsevimab shot also a possibility for some at-risk toddlers

A photo of three vials of compounded semaglutide.

FDA Warns on Certain Forms of Compounded Semaglutide

Some products may not contain the same active ingredient as the approved drugs

FDA APPROVED olaparib (Lynparza) over a computer rendering of prostate cancer.

FDA OKs Olaparib-Abiraterone for Metastatic Prostate Cancer

Approval limited to BRCA-positive subset

FDA APPROVED Unadjuvanted, bivalent RSV prefusion F protein vaccine (Abrysvo) over a computer rendering of RSV viruses.

Second RSV Vaccine Lands Approval for Older Adults

Abrysvo approved for adults 60 and up

A photo of an unhappy looking overweight boy sitting on a piece of gym equipment.

What Happens When We Classify Kids' Weight as a 'Disease'?

The AAP obesity guidelines stand to worsen stigma and mental health

FDA APPROVED sotagliflozin (Inpefa) over a photo of a flatlining vital sign monitor.

Sotagliflozin Gets FDA's Blessing for Heart Failure

SGLT1/SGLT2 inhibitor approved on the basis of SOLOIST-WHF, SCORED trials

A photo of a woman standing in front of shelves of products in a pharmacy.

Tackling Barriers to OTC Birth Control Pills

FDA approval would be a critical step, but we must address other access issues

FDA APPROVED nalmefene hydrochloride nasal spray (Opvee) over a photo of a police officer holding a similar device.

New Type of Opioid Reversal Agent Approved

Longer-acting nasal spray to be available by end of the year

FDA ADCOMM obeticholic acid (Ocaliva) over a computer rendering of a liver with fibrosis.

Ocaliva for NASH Gets Thumbs Down From FDA Advisors

Difficulty of risk mitigation for potential drug-induced liver injury weighed heavily on members

FDA APPROVED herpes-simplex virus type 1 vector-based gene therapy (Vyjuvek) over a photo of dystrophic epidermolysis bullosa

Rare Skin Blistering Condition Gets First Drug Approved

FDA's decision marks first approval for a redosable gene therapy

FDA 'Leans In' to Accelerated Approval for Rare Disease Drugs

CBER director says "moment is tender for gene therapy," sees opportunity to "salvage" treatments

A photo of a little boy in a wheelchair.

Should FDA Grant Accelerated Approval to Duchenne Muscular Dystrophy Gene Therapy?

Waiting for the results of the SRP-9001 confirmatory trial may be a better move

FDA APPROVED upadacitinib (Rinvoq) over a computer rendering of inflamed intestines in a transparent body.

First JAK Inhibitor Approved for Crohn's Disease

Upadacitinib lands indication for moderately to severely active disease in adults

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