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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

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

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

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.

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.

FDA Reviewers Raise Multiple Issues on OTC Birth Control Pill

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

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.

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.

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.

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.

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.

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.

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.

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.

Thumbs Down From FDA Panel on Plastic Meniscus Replacement

Members unimpressed with efficacy, safety data

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.

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.

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.

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.

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.

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.

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.

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.

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.

FDA Approval Authority in Jeopardy? TB Hits the Casino; Sen. Blumenthal's Surgery

Health news and commentary from around the Web gathered by 麻豆传媒 staff

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.

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.

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.

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

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