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FDA General

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Psychedelic Research: Experts React to FDA Draft Guidance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

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

NASH Drug Candidate Comes With 'Serious Risks,' Says FDA Staff

Agency reviewers signal little support for first potential nonalcoholic steatohepatitis drug

A photo of a physiotherapist assisting a patient with amyotrophic lateral sclerosis

The Broader Significance of a New Drug for a Rare Form of ALS

The tofersen trial offers hope and lessons for the fight against ALS

FDA ADCOMM delandistrogene moxeparvovec (SRP-9001) over a physical therapist working with child with muscular dystrophy

Duchenne Muscular Dystrophy Treatment Narrowly Captures Support of FDA Advisors

Whether vote means FDA will approve Sarepta's gene therapy remains to be seen

FDA APPROVED fezolinetant (Veozah) over a photo of a mature woman on a couch fanning herself.

FDA OKs Hormone-Free Pill for Hot Flashes

First-in-class drug works by blocking the NK3 receptor, which plays role in regulating body temp

A photo of Senator Chuck Schumer holding a photo of a bottle of xylazine.

Bill to Study Xylazine Passes House, Advances in Senate

Measure does not address scheduling the drug, which is frequently added to fentanyl

An out-of-focus photo of the back of a medication describing precautions and instructions

FDA Updates Warnings on All Stimulants for ADHD, Other Conditions

New language emphasizes potential for misuse, abuse, addiction, and overdose

FDA ADCOMM epinephrine nasal spray (neffy) over a photo of a man holding this nasal spray

FDA Panel Backs Needle-Free Epinephrine for Anaphylaxis

Choice of alternative route with nasal spray outweighs possible risks, panelists say

A photo of a man looking at his smartphone while donating blood.

FDA Relaxes Blood Donation Rules for Gay and Bisexual Men

New guidance ditches MSM-specific screening questions in effort to expand eligibility

FDA APPROVED brexpiprazole (Rexulti) over a photo of a agitated-looking senior woman.

FDA OKs First Drug for Agitation in Alzheimer's Dementia

Boxed warning on increased mortality risk in elderly patients remains for brexpiprazole

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