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

FDA Warns of Unapproved Fat-Dissolving Injections

Users have experienced permanent scars, infections

A photo of a mature man coughing.

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.

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

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

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.

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.

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

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.

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.

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.

FDA OKs Maintenance Option for High-Risk Neuroblastoma

Eflornithine approved to reduce relapse risk in both kids and adults

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.

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.

FDA Inspections of Foreign Drug Manufacturers Haven't Bounced Back After Pandemic

Overseas inspections "well below" pre-pandemic surveillance

FDA APPROVED exagamglogene autotemcel (Casgevy) and lovotibeglogene autotemcel (Lyfgenia) over an image of a sickle cell.

Milestone Gene Therapies for Sickle Cell Disease Greenlit by FDA

Casgevy and Lyfgenia approved for one-time treatment of sickle cell disease

A photo of the components of the Mosie Baby Kit

FDA Clears First At-Home Kit for Artificial Insemination

Intravaginal device was deemed "substantially equivalent" to clinically used intrauterine device

FDA APPROVED iptacopan (Fabhalta) over a computer rendering of damaged red blood cells.

FDA Approves Oral Factor B Inhibitor for Paroxysmal Nocturnal Hemoglobinuria

Iptacopan tops C5 Inhibitors for sustained hemoglobin levels, eliminating need for transfusion

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

Jamie Foxx's Health Scare; 23andMe Hacked; Decongestant Probe Announced

Health news and commentary from around the Web gathered by 名媛直播 staff

A close up photo of a lit cigarette in a man's fingers.

Don't Neglect Tobacco Use in People Experiencing Homelessness

Cessation programs can save lives and improve financial stability

Gaming the Patent System Can Keep Biosimilars Off the Market for Decades

Sean Tu, PhD, JD, explains trade secret laws and patent laws for biologics

FDA APPROVED pirtobrutinib (Jaypirca) over a computer rendering of chronic lymphocytic leukemia cells.

Non-Covalent BTK Inhibitor Approved for CLL

Response rates with pirtobrutinib reached 72% in heavily pretreated patient population

Photos of removable oral appliances from Vivos Therapeutics.

FDA Clears First Oral Device Treatment for Severe Sleep Apnea

Oral appliances represent an alternative to CPAP and surgical neurostimulation implants

FDA WARNING Philips DreamStation 2 over a photo of a man pressing a button on a DreamStation 2 device.

FDA Warns That Philips' CPAP Machines May Overheat

Thermal issues including burns, smoke, fire among reports submitted by DreamStation 2 users

A computer rendering of numerous eosinophils in the blood.

FDA Warns of Rare Life-Threatening Reaction to Anti-Seizure Drugs

Prescribing information changed for levetiracetam, clobazam

A scanning electron microscope image of CAR-T cells attacking a cancer cell.

FDA Investigating 'Serious Risk' of Malignancy After CAR-T Therapy

Applies to all approved therapies, but benefits still outweigh risks, agency says

FDA APPROVED nirogacestat (Ogsiveo) over a computer rendering of a connective tissue tumor.

FDA Approves First Therapy for Progressive Desmoid Tumors

Nirogacestat reduced the risk of disease progression or death by 71% in randomized trial

A photo of crates of medical supplies at the Strategic National Stockpile

Biden Administration Announces Actions to Strengthen the Drug Supply Chain

Biden will use the Defense Production Act to increase American production of some medications

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

Devastating Medication Error; FDA's Recall Weakness; Insurers Break State Laws

This past week in healthcare investigations

A photo of eye care products on the shelves of a CVS pharmacy.

What to Know About Ongoing Eye Drop Recalls

FDA was spurred into action by a deadly bacterial outbreak earlier this year, advocates say

FDA ADCOMM gefapixant oral tablets over a photo of a mature man coughing.

Drug Candidate for Chronic Cough Rejected by FDA Panel

Gefapixant's benefit not clinically meaningful enough, panelists say

FDA APPROVED capivasertib (Truqap) over a computer rendering of breast cancer.

First AKT Inhibitor Approved for Advanced Breast Cancer

Capivasertib plus fulvestrant doubled progression-free survival versus fulvestrant-placebo

FDA ADCOMM pralatrexate (Folotyn), belinostat (Beleodaq) over a computer rendering of lymphoma cells in the blood flow.

FDA Panel: Tolerating Approval Outliers Would Set 'Dangerous Precedent'

No easy answers for two drugs for rare lymphoma on long cruise with accelerated approval

A close up photo of a healthcare worker drawing blood from the finger of a little boy to test for lead.

What to Know About Lead Toxicity and Kids' Applesauce

Hospitalization for acute lead toxicity can start at 45 mcg/dL

FDA MARKETING Diagnostic test for chlamydia and gonorrhea with at-home sample collection (Simple 2 Test) over the product.

First At-Home Test for Chlamydia and Gonorrhea Authorized by FDA

OTC option arrives amid rising cases of the sexually transmitted infections

FDA APPROVED repotrectinib (Augtyro) over a computer rendering of a transparent body with lung cancer highlighted.

FDA OKs New Option for Advanced ROS1-Positive Lung Cancer

Drug achieved high response rates in TKI-naive and TKI-pretreated patients

FDA ADCOMM gefapixant oral tablets over a photo of a mature man coughing.

Unclear if Chronic Cough Drug Has Meaningful Benefit, FDA Reviewers Say

Previously rejected gefapixant will face agency's panel of outside experts on Friday

FDA ADCOMM taurolidine + heparin catheter lock solution (Defencath) over a photo of a man receiving dialysis.

FDA OKs Product to Thwart Bloodstream Infections During Dialysis

Taurolidine-heparin solution reduced infections by 71% versus heparin alone

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

Anthrax Guidance Issued; FDA Warns Amazon; AI Deepfakes Challenge Public Health

Health news and commentary from around the Web gathered by 名媛直播 staff

A photo of the vial and packaging of Aliqopa.

Lymphoma Drug Copanlisib to Be Pulled From U.S. Market

Failed confirmatory trial takes down another PI3K inhibitor

Communicating Uncertainty About Drugs Granted Accelerated Approval

An education gap exists about "the possibility that these drugs might not work," says expert

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