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Months after advisors recommended Makena's approval be withdrawn, FDA announces final decision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

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

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

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

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.

FDA Panel Supports Tofersen for Rare Genetic ALS

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

FDA APPROVED retifanlimab (Zynyz) over a photo of a woman with Merkel cell carcinoma on her ear

FDA OKs Another PD-1 Inhibitor for Merkel Cell Carcinoma

Retifanlimab produced responses in 52% of patients with untreated unresectable disease

A photo of the signage outside of the FDA headquarters in Washington, D.C.

FDA Has Neglected Clinical Trial Transparency 鈥� Plus $45 Billion in Fines

It's time for more aggressive enforcement of the law

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

Investigational ALS Drug May Have Clinical Benefit, FDA Staff Says

Neurofilament light will be evaluated as a surrogate endpoint in tofersen review

FDA MARKETING Copenhagen Classic Snuff over a photo of a man opening a can of snuff.

FDA Allows Lower Risk Designation for Snuff Product

The brand joins a limited few granted modified risk tobacco claims

A photo of Joseph Ladapo, MD, PhD

CDC, FDA Heads Fire Back at Ladapo Letter

Califf and Walensky say Florida Surgeon General's VAERS analysis is "incorrect, misleading"

FDA ODAC polatuzumab vedotin (Polivy) over a microscopy of B-cell lymphoma cells.

FDA Panel Endorses New First-Line Lymphoma Regimen

POLARIX trial supports a favorable risk-benefit profile for polatuzumab vedotin, ODAC members say

FDA APPROVED Bimodal neuromodulation device (Lenire) over a photo of a man using the Lenire device.

First Bimodal Neuromodulation Device for Tinnitus Gets FDA Nod

Ringing ears may get relief with sound and tongue stimulation

Only Drug to Prevent Preterm Birth Set to Leave the Market

Decision follows FDA advisory committee recommendation for withdrawal

FDA ODAC polatuzumab vedotin-piiq (Polivy) over a micrograph of diffuse large B-cell lymphoma

FDA Not Quite Sold on Polivy in Frontline Large B-Cell Lymphoma Regimen

Ahead of ODAC meeting, agency reviewers suggest modest PFS results in POLARIX "raise uncertainty"

A photo of loose tablets next to a prescription bottle of hydrocodone/APAP tablets.

FDA Mandate on Acetaminophen-Opioid Combinations Appeared Effective

Hospitalizations for liver toxicity declined after FDA limited acetaminophen dose

FDA APPROVED omaveloxolone (Skyclarys) over a photo of a man with Friedreich鈥檚 ataxia in a wheelchair outside.

First Treatment Approved for Rare Neurodegenerative Disorder

Omaveloxolone gets FDA nod for Friedreich's ataxia

FDA ADCOMM omecamtiv mecarbil over a computer rendering of a heart attack.

Omecamtiv Mecarbil for Heart Failure Turned Down by FDA

End of the road for cardiac myosin activator

A photo of a vial of xylazine on the counter in a veterinary clinic

FDA Issues Import Alert on 'Tranq' Drug Xylazine

Drug will be under added scrutiny to make sure it's for "legitimate veterinary use," agency says

A photo of a woman holding a mifepristone tablet in her hand next to the box.

A Ban on the Abortion Drug Mifepristone Is Looming

A Texas lawsuit may be disastrous for effective abortion access and FDA's authority

A photo of a box of Narcan Nasal Spray sitting on a marble counter top.

Over-the-Counter Naloxone Has the Power to Save Lives

But removing barriers to access is an essential next step

INVESTIGATIVE ROUNDUP over an image of two people looking at computer screens.

Alzheimer's Data Faked? Docs 'Groomed' to Overuse Devices; Orphan Drug Fight

This past week in healthcare investigations

FDA APPROVED pegcetacoplan injection (SYFOVRE) over a photo of a roadway with a dark spot obscuring the center of the image.

FDA Approves First Treatment for Geographic Atrophy Secondary to AMD

Pegcetacoplan reduced GA lesion growth by 22% over 24 months versus sham injections

FDA APPROVED velmanase alfa (Lamzede) over a photo of two toddler boys affected by alpha-mannosidosis

FDA OKs First Therapy for Alpha-Mannosidosis

Velmanase alfa approved for treating non-CNS manifestations of progressive, inherited disease

FDA ADCOMM OTC Narcan over a photo of Narcan nasal spray.

Proposed User Instructions for OTC Narcan Has FDA Concerned

In emergency setting, proper use and administration by consumer is "essential," says agency staff

What Happened to the Monoclonal Antibodies for COVID-19?

Losing focus on monoclonals means neglecting those who need them most: the immunocompromised

A photo a nurse preparing medication for parenteral nutrition

FDA Warns on Use of Hospira Drug in Kids Due to 'Unsafe' Aluminum Levels

Agency cites risk for aluminum toxicity in infants

FDA ODAC dostarlimab (Jemperli) over an MRI image of rectal cancer.

FDA Has Concerns on 'Unprecedented' Plan for Dostarlimab in Rectal Cancer

Panel will discuss if single-arm trials and proposed endpoints are adequate to support approval

A photo composite of a measuring tape and a Wegovy injection pen.

Do Weight-Loss Startups Have a Future?

Here are my predictions for the industry

A photo of a male physician standing between a young adult male and female receiving infusion therapy and reading magazines.

Ketamine Clinics Are Jumping Ahead of the Evidence

New mental health treatments must be approached with caution

How Patent Thickets Keep Cheaper Drugs Off the Market

"We're transferring a huge amount of wealth from the public to drug companies," says S. Sean Tu

A photo of a vial of xylazine for injection over a photo of small bags of white powder.

What Doctors Should Know About Xylazine in Fentanyl

Naloxone still works but additional support may be needed; wound care a challenge

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