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FDA General

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

<乌鸦传媒>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

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>FDA OKs First Drug for Agitation in Alzheimer's Dementia

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

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

<乌鸦传媒>Sarepta's Duchenne Gene Therapy Does Not Have 'Unambiguous Evidence,' FDA Staff Says

Agency reviewers question micro-dystrophin as a surrogate endpoint

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

<乌鸦传媒>FDA Staff Grapples With Absent Clinical Efficacy Data for Nasal Epinephrine

No precedent for approval of noninjectable epinephrine for anaphylaxis, noted agency reviewers

A photo of a female radiologist performing a mammography on her Black patient.

<乌鸦传媒>Proposed Breast Cancer Screening Guidelines Are Good, but Not Enough

Specifics for older women, Black women, and those with dense breasts are needed

FDA ADCOMM OTC birth control pill (Opill) over a photo of a woman holding a blisterpack of oral contraceptives.

<乌鸦传媒>FDA Reviewers Raise Multiple Issues on OTC Birth Control Pill

Is labeling enough for users to take the drug correctly and self-deselect?

<乌鸦传媒>Forging the Path to a West Nile Vaccine

Alternative approaches to licensure are key, says CDC's Carolyn Gould

A photo of a blue rubber gloved hand holding a pre-filled syringe.

<乌鸦传媒>Why Is One Dose Suddenly Enough for the mRNA COVID Vaccines?

FDA and CDC have made yet another questionable decision

FDA olaparib (Lynparza) + abiraterone (Zytiga) over a computer rendering of prostate cancer.

<乌鸦传媒>FDA Panel Rejects Broad Olaparib Indication in Metastatic CRPC

ODAC votes that olaparib-abiraterone combination should be restricted to BRCA-positive subset

A photo composition of computer rendered COVID viruses over a photo of a woman on a couch feeling dizzy.

<乌鸦传媒>Patients Living With Long COVID Offer Insight to FDA

Agency sought feedback on outcomes that matter most to patients

FDA APPROVED elexacaftor/tezacaftor/ivacaftor (Trikafta) over a photo of a little girl on a couch using a nebulizer.

<乌鸦传媒>FDA Extends Trikafta Approval to Even Younger Cystic Fibrosis Patients

Patients ages 2 to 5 years now eligible for the triple therapy

FDA APPROVED Vowst over a microscope image of C. difficile bacteria.

<乌鸦传媒>FDA OKs First Poop-Based Oral Therapy

Vowst approved for preventing recurrent C. difficile infections after antibiotics

A photo of boxes of Regener-Eyes and StimulEyes eye drops.

<乌鸦传媒>Be Wary of Amniotic Fluid Eye Drops, FDA Says

Agency sends another salvo in battle with birth-tissue industry

FDA APPROVED MiniMed 780G system over a photo a person holding the device.

<乌鸦传媒>FDA Finally OKs Latest MiniMed System for Type 1 Diabetes

780G system first to feature meal detection technology

FDA ADCOMM NUsurface Meniscus Implant over a photo of the device.

<乌鸦传媒>Thumbs Down From FDA Panel on Plastic Meniscus Replacement

Members unimpressed with efficacy, safety data

<乌鸦传媒>Who Are the Doctors Suing FDA Over the Abortion Pill?

Four physicians are named as plaintiffs alongside the Alliance for Hippocratic Medicine

A photo of Morphine Sulfate ER tablets in a person鈥檚 hand.

<乌鸦传媒>FDA Panelists Slam Agency's Proposed Opioid Trial Design

Advisors said outcomes from an enriched enrollment study would not be broadly generalizable

FDA APPROVED polatuzumab vedotin (Polivy) over a computer rendering of antibodies attacking a cancer cell.

<乌鸦传媒>Antibody-Drug Conjugate Gets FDA Thumbs Up for Untreated DLBCL

Adding polatuzumab vedotin to a modified version of R-CHOP significantly improved PFS

A photo of Morphine Sulfate ER tablets in the palm of a person鈥檚 hand.

<乌鸦传媒>FDA Mulling Trial Design Issues for Long-Term Opioids in Chronic Pain

Agency advisors will consider pros, cons of an enriched enrollment randomized withdrawal design

FDA ADCOMM brexpiprazole (Rexulti) over a photo of an agitated senior woman rising her index finger.

<乌鸦传媒>FDA Advisors Endorse Rexulti for Agitation in Alzheimer's Dementia

Increased mortality risk seen but benefits may outweigh this, panelists say

FDA ADCOMM sulbactam-durlobactam over a photo of a man on a ventilator in the ICU.

<乌鸦传媒>FDA Panel to Weigh Limited Data on Combo for Healthcare-Acquired Pneumonia

Sulbactam-durlobactam under consideration for cases caused by Acinetobacter spp.

A photo of signage outside of the FDA headquarters in White Oak, Maryland.

<乌鸦传媒>All Opioid Pain Meds to Get New Safety Warnings, FDA Says

Updated labeling to include warning about opioid-induced hyperalgesia

FDA ADCOMM brexpiprazole (Rexulti) over a photo of an agitated senior woman rising her index finger.

<乌鸦传媒>Rexulti Works for Agitation in Alzheimer's, Despite Risks, Says FDA Staff

Increased mortality risk consistent with other antipsychotics in elderly dementia patients

FDA ALERT Certain Philips Respironics DreamStation breathing devices over a photo of a DreamStation1 device.

<乌鸦传媒>Reworked Philips CPAP, BiPAP Machines May Not Deliver Correct Therapy

And some of the remediated breathing devices may not provide any treatment at all, FDA warns

Morning Break over illustration of a syringe, Covid virus, and DNA helix over a photo of green vegetation.

<乌鸦传媒>FDA Approval Authority in Jeopardy? TB Hits the Casino; Sen. Blumenthal's Surgery

Health news and commentary from around the Web gathered by 乌鸦传媒 staff

<乌鸦传媒>FDA Yanks Only Preterm Birth Drug, Effective Immediately

Months after advisors recommended Makena's approval be withdrawn, FDA announces final decision

A photo of a senior man putting a white box into a padded envelope.

<乌鸦传媒>Mail-Back Envelopes Will Be Dispensed With Outpatient Opioid Scripts

Strategy will provide another option to dispose of unneeded medications, FDA says

FDA ADCOMM isotretinoin REMS (iPledge) over a close up photo of a woman with severe acne on her face.

<乌鸦传媒>Do Away With 'Lockout' Period in iPLEDGE, FDA Advisors Urge

It's an "unduly high burden" on patients, says one advisory committee member

FDA ADCOMM isotretinoin REMS (iPledge) over a close up photo of a woman with severe acne on her face.

<乌鸦传媒>Isotretinoin REMS Still Needed, but Its Burden Could Be Reduced, FDA Staff Says

Report suggests ways to lighten documentation rules for prescribing the severe acne treatment

FDA APPROVED leniolisib (Joenja) over a photo of a female physician palpating her mature male patients lymph nodes.

<乌鸦传媒>FDA Greenlights First Drug for Rare Immunodeficiency Disease

Activated PI3K-delta syndrome may have a new standard of care

A photo of the Olympus single-use duodenoscope

<乌鸦传媒>FDA Faults Next-Gen Olympus Duodenoscopes

After demanding single-use devices, agency finds they have their own problems

FDA SAFETY Exactech joint replacement devices over a photo of Exactech knee replacement devices

<乌鸦传媒>FDA: Watch for Joint Replacement Device Failure After Exactech Recall

Revision surgery only recommended for patients with pain

FDA APPROVED tofersen over a computer rendering of a damaged motor neuron.

<乌鸦传媒>FDA Panel Supports Tofersen for Rare Genetic ALS

In a first, agency advisors back neurofilament light as a surrogate endpoint

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