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FDA General

A computer rendering of CAR T cells and a cancer cell.

<乌鸦传媒>FDA Calls for New Boxed Warning on All CAR-T Products

Most serious warning would alert patients, providers on potential risk for secondary malignancies

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

<乌鸦传媒>New FDA Boxed Warning; College Shaken by Suicides; More Get Flu Shot Than COVID Vax

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

A photo of vials of XoGlo and XoGloPro and Amnio2X

<乌鸦传媒>FDA Warns Exosome Maker for Marketing Outside Its IND

Agency also raises concern about a potentially contaminated product batch

The FDA and CMS logos on two computer rendered joined puzzle pieces

<乌鸦传媒>The Healthcare Landscape Is Changing. Our Regulatory Practices Should Too.

Closer collaboration between FDA and CMS is the need of the hour

A photo of FDA APPROVED laying on the U.S. flag.

<乌鸦传媒>Physicians Don't Always Understand the FDA Approval Process, Survey Finds

Most preferred two or more randomized trials as evidence required for approval

A photo of anti-tobacco activists and their supporters during the menthol funeral in New York City.

<乌鸦传媒>Anti-Tobacco Activists Hold 'Menthol Funeral' in Washington

Speakers urge Biden to release long-delayed final rule banning menthol-flavored tobacco products

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

<乌鸦传媒>King Charles III's Surgery; COVID Timeline Doubted; FDA Approvals Hit High

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

FDA CLEARED DermaSensor over a computer rendering of the device in use.

<乌鸦传媒>FDA Clears AI-Powered Non-Invasive Skin Cancer Detector

Intended for use in primary care, handheld device is first of its kind

A scanning electron microscope image of COVID particles emerging from the surface of a cell

<乌鸦传媒>Novel Antiviral Shortens COVID Illness in Outpatients, Reduces Viral Load

But trial did not provide data on the most clinically relevant outcomes, says expert

A photo of signage outside of MiMedx headquarters in Marietta, Georgia.

<乌鸦传媒>Company Warned Over Human Placenta Product

FDA tells MiMedx that its wound-healing product must be regulated as a biologic drug

FDA APPROVED Pembrolizumab (Keytruda) with chemoradiotherapy (CRT) over a computer rendering of cervical cancer cells.

<乌鸦传媒>FDA Expands Pembrolizumab Approval in Cervical Cancer

PD-1 inhibitor approved in combination with CRT for locally advanced disease

A photo of a man holding a handmade sign which reads: You can鈥檛 be worth $11 billion and declare bankruptcy!

<乌鸦传媒>The Sackler Family Can Act Today to Compensate Opioid Overdose Victims

But it appears unlikely they will take this course of action

A photo of Rep. Greg Murphy, MD (R-N.C.)

<乌鸦传媒>Medicare Doc Payment Fix Bill Moving Along, GOP Doctors Caucus Co-Chair Says

Rep. Greg Murphy, MD, is hoping for action within a week

A photo of Wegovy injection pens.

<乌鸦传媒>FDA Clears Wegovy, Other GLP-1 Drugs of Suicidality Risk for Now

Preliminary evaluation reassures, while the agency's review continues

<乌鸦传媒>Was the Name 'Operation Warp Speed' Misleading?

Paul Offit reflects on how FDA communication may have led to vaccine hesitancy

FDA APPROVED berdazimer gel (Zelsuvmi) over a photo of molluscum contagiosum warts on the thigh of a child

<乌鸦传媒>At-Home Treatment for Molluscum Contagiosum Wins FDA Approval

Berdazimer gel led to 30% complete/near-complete clearance after 12 weeks in randomized trials

A photo of bottles of prescription medication and a stethoscope laying on a Canadian flag puzzle in the shape of Canada

<乌鸦传媒>FDA Approves Florida's Proposal to Import Prescription Drugs From Canada

Drugmakers say they're "considering all options" in response

<乌鸦传媒>Paul Offit Debunks Florida Surgeon General's Anti-Vax Warning

"It is hard to believe that Dr. Ladapo actually issued that statement," said vaccine expert

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

<乌鸦传媒>U.S. Rep's Death Medical Negligence? FDA Investigates GLPs; Fingerprint Mammograms

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

FDA WARNING Certain tejocote root supplements over a photo of yellow oleander flowers.

<乌鸦传媒>FDA Warns of Toxic Oleander in Supplements

Dangerous substitution once again found in tejocote root products

<乌鸦传媒>FDA Warns Amazon Over Supplements Containing Erectile Dysfunction Drugs

Agency bought and tested products that were found to contain tadalafil and sildenafil

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

<乌鸦传媒>Bernie Sanders Has COVID; Global Fake Ozempic Problem; Nitazenes, the New Fentanyl?

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

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

<乌鸦传媒>Ketamine and Chronic Pain; Ivermectin Lawsuit and Public Health; JN.1 Keeps Growing

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

A photo of signage outside of FDA headquarters in Silver Spring, Maryland.

<乌鸦传媒>Deep Flaws in FDA's Device Oversight, and Patient Harm, Exposed in Lawsuits, Records

"What is the threshold for the FDA to step in and do something?"

FDA APPROVED eplontersen (Wainua) over a computer rendering of amyloidosis

<乌鸦传媒>FDA Approves New Agent for Nerve Pain From Rare Inherited Disease

Eplontersen gets a nod for polyneuropathy from hereditary transthyretin-mediated amyloidosis

A photo of a man holding an Ozempic injection pen.

<乌鸦传媒>Beware of Fake Ozempic, FDA Warns

Agency seized thousands of counterfeit units already

A photo of a female dermatologist performing a fat-dissolving injection

<乌鸦传媒>FDA Warns of Unapproved Fat-Dissolving Injections

Users have experienced permanent scars, infections

A photo of a mature man coughing.

<乌鸦传媒>FDA Rejects Drug for Chronic Cough

Agency cites efficacy concerns in review of P2X3 receptor antagonist gefapixant

FDA APPROVED AvertD test over a photo of the product.

<乌鸦传媒>First Test to Identify Opioid Addiction Risk Approved by FDA

Genetic test intended to be used before patients are exposed to oral opioids for acute pain

A photo of an Olympus bronchovideoscope

<乌鸦传媒>Bronchoscopes Recalled Over Burns, Fires in Patients' Airways

Reports involved Olympus scopes used during high-frequency cauterization while supplying oxygen

FDA APPROVED Birch triterpenes (Filsuvez) over a photo of a little girl affected by epidermolysis bullosa

<乌鸦传媒>Topical Treatment for Epidermolysis Bullosa Wins FDA Approval

Significantly more wounds healed within 45 days with birch triterpenes gel than with control gel

FDA APPROVED enfortumab vedotin-ejfv (Padcev) + pembrolizumab (Keytruda) over a computer rendering of bladder cancer.

<乌鸦传媒>FDA Approves New First-Line Standard of Care in Bladder Cancer

Enfortumab vedotin plus pembrolizumab doubled survival as compared with chemotherapy

FDA approved belzutifan (Welireg) over a computer rendering 0f a tumor on a kidney.

<乌鸦传媒>FDA Approves Belzutifan for Advanced Renal Cell Carcinoma

HIF-2 inhibitor indicated for patients who progress after immunotherapy and anti-VEGF

FDA APPROVED travoprost intracameral implant (iDose TR) over a computer rendering of the device

<乌鸦传媒>Implant for Ocular Hypertension, Glaucoma Gets FDA Green Light

A single travoprost implant proved noninferior to timolol eye drops, with good safety

FDA APPROVED PulseSelect PFA system over a photo of the device.

<乌鸦传媒>First Pulsed Field Ablation Catheter Approved for Afib

Device is the first of a new class of non-thermal ablation catheters to get FDA's blessing

A photo of a man handing his credit card to a woman working at a pharmacy.

<乌鸦传媒>Experts, Lawmakers Explore Downside of Drug-Price Negotiation

Stifled innovation, reduced access suggested as future challenges

FDA approved oral eflornithine (Iwilfin) over a computer rendering of a tumor of the adrenal gland.

<乌鸦传媒>FDA OKs Maintenance Option for High-Risk Neuroblastoma

Eflornithine approved to reduce relapse risk in both kids and adults

<乌鸦传媒>The FDA's Inequitable Conduct Problem

Study finds that about half of all inequitable conduct cases were for FDA-regulated products

A computer rendering of DNA editing with CRISPR.

<乌鸦传媒>A Closer Look at the Approval of CRISPR/Cas9 Gene Therapy for Sickle Cell Disease

This landmark event brings up broader considerations and implications for other diseases

A photo of a TEVA chemical plant in Ramat, Hovav, Israel.

<乌鸦传媒>FDA Inspections of Foreign Drug Manufacturers Haven't Bounced Back After Pandemic

Overseas inspections "well below" pre-pandemic surveillance

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