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FDA General

A photo of Robert Califf, MD

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>First OTC Birth Control Pill Approved

Sea change for pregnancy prevention

A photo of the vial and packaging of Leqembi.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>Alzheimer's Drug Wins Full FDA Approval

Decision expands lecanemab's Medicare coverage

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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

<乌鸦传媒>Rare Skin Blistering Condition Gets First Drug Approved

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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>First JAK Inhibitor Approved for Crohn's Disease

Upadacitinib lands indication for moderately to severely active disease in adults

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