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FDA General

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

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>First Bimodal Neuromodulation Device for Tinnitus Gets FDA Nod

Ringing ears may get relief with sound and tongue stimulation

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>Proposed User Instructions for OTC Narcan Has FDA Concerned

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

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>Do Weight-Loss Startups Have a Future?

Here are my predictions for the industry

<乌鸦传媒>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.

<乌鸦传媒>What Doctors Should Know About Xylazine in Fentanyl

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

FDA APPROVED elacestrant (Orserdu) over a computer rendering of breast cancer.

<乌鸦传媒>FDA Greenlights First Drug for ESR1-Mutated Breast Cancer

Elacestrant almost doubled PFS versus standard endocrine therapy in advanced ER+/HER2- disease

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

<乌鸦传媒>Doc Delivered Deadly Epidural; Hotze's Conspiracy Theory; Docs Slam Wegovy Story

This past week in healthcare investigations

A photo of Frank Pallone during a hearing.

<乌鸦传媒>FDA, NIH Must Penalize Researchers Who Don't Report Trial Results, House Member Says

Many with NIH grants don't follow reporting rules, get funded again anyway, says Rep. Pallone

A photo of a box of the Pfizer-BioNTech bivalent COVID-19 vaccine

<乌鸦传媒>CDC, FDA Flag Early Signal of Stroke Risk With Bivalent COVID Vaccine

One surveillance system detects potential link in seniors, yet multiple others show none

<乌鸦传媒>Legal Loophole Lets Faulty Devices Maintain Their Legacy

Harlan Krumholz on how devices subject to Class I recalls are used as predicates for new devices

FDA APPROVED Lecanemab-irmb (Leqembi) over a computer rendering of amyloid plaques forming between neurons

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

Anti-amyloid showed modest benefit in phase III trial, but was linked to adverse events

A photo of the packaging and blisterpack of a Mifeprex pill

<乌鸦传媒>Abortion Pill Can Be Dispensed in Retail Pharmacies, FDA Says

Decision allows patients to pick up mifepristone at brick-and-mortar locations

A computer rendering of a macrophage and cancer cells.

<乌鸦传媒>Crystal Ball Cloudy for PI3K Inhibitors' Future in Hematology

After a year of negative news, some caution about throwing out the baby with the bath water

FDA APPROVED ublituximab (Briumvi) over a computer rendering of a motor neuron with a degrading myelin sheath

<乌鸦传媒>Anti-CD20 Agent Gains Approval for Multiple Sclerosis

FDA greenlights ublituximab for relapsing MS

FDA APPROVED semaglutide 2.4 mg (Wegovy) over a photo of a teen girl laying on grass taking a selfie.

<乌鸦传媒>Wegovy OK'd for Teens With Obesity

New indication for popular weight-loss injectable

A photo of canisters of Enfamil on mostly empty store shelves.

<乌鸦传媒>No, the Baby Formula Shortage Still Isn't Over

Experts say regulatory changes treat symptoms but not all causes of the formula crisis

A photo of Charles Venditti, MD, PhD, meeting with a young female patient.

<乌鸦传媒>Families Push Research Forward in Rare Diseases

The field has a unique funding model. While fruitful, some question if it needs to change.

FDA APPROVED nadofaragene firadenovec-vncg (Adstiladrin) over a computer rendering of bladder cancer.

<乌鸦传媒>FDA Approves First Gene Therapy for Non-Muscle-Invasive Bladder Cancer

Half of patients achieved complete responses with adenoviral vector-based product

A photo of the headquarters of US Food and Drug Administration in Silver Spring Maryland

<乌鸦传媒>'Constant Turmoil' at FDA Makes Our Food Less Safe

Reflections on a new report about the agency's Human Foods Program

A photo of a Makena auto-injector pen laying on a shelf in a medicine cabinet.

<乌鸦传媒>Why Does Makena Remain on the Market?

Misguided equity claims do not resolve issues with the accelerated approval program

FDA APPROVED olutasidenib (Rezlidhia) over a computer rendering of acute myeloid leukemia cells.

<乌鸦传媒>New IDH1 Inhibitor Wins FDA Approval for Acute Myeloid Leukemia

Olutasidenib led to a 35% response rate in a study of adults with previously treated AML

FDA APPROVED Fecal microbiota, live (Rebyota) over a computer rendering of Clostridioides difficile bacteria.

<乌鸦传媒>FDA Greenlights First Fecal Microbiota Product

Rebyota approved for preventing recurrence of C. difficile infection

A kidney patient receives treatment at a hospital.

<乌鸦传媒>Watch for Severe Hypocalcemia in Dialysis Patients on Prolia, FDA Warns

Agency said potential risk may require more frequent blood calcium monitoring

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