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FDA General

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

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

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

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>Doc Set Home on Fire? High Blood Pressure in Couples; WHO: Raise Alcohol, Soda Taxes

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

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

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

<乌鸦传媒>Don't Neglect Tobacco Use in People Experiencing Homelessness

Cessation programs can save lives and improve financial stability

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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

<乌鸦传媒>Biden Administration Announces Actions to Strengthen the Drug Supply Chain

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

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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>First AKT Inhibitor Approved for Advanced Breast Cancer

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

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

<乌鸦传媒>Opioid Doc Sentenced; World's First Sickle Cell Gene Tx; FTC Warns Diet Influencers

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

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

<乌鸦传媒>FDA Panel: Tolerating Approval Outliers Would Set 'Dangerous Precedent'

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

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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>Anthrax Guidance Issued; FDA Warns Amazon; AI Deepfakes Challenge Public Health

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

A photo of the vial and packaging of Aliqopa.

<乌鸦传媒>Lymphoma Drug Copanlisib to Be Pulled From U.S. Market

Failed confirmatory trial takes down another PI3K inhibitor

<乌鸦传媒>Communicating Uncertainty About Drugs Granted Accelerated Approval

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

FDA APPROVED ADAMTS13, recombinant-krhn (Adzynma) over a computer rendering of a blood clot.

<乌鸦传媒>First Treatment Approved for Genetic Clotting Disorder

Adzynma indicated as prophylactic or on-demand enzyme replacement therapy in cTTP

FDA APPROVED Chikungunya vaccine (Ixchiq) over a transmission electron microscope image of chikungunya viruses.

<乌鸦传媒>First Chikungunya Vaccine Lands Conditional FDA Approval

High level of seroprotection, but adverse reactions warrant postmarketing study

<乌鸦传媒>Competing Incentives of the FDA's Accelerated Drug Approval

Experts weigh drug availability against possible suboptimal outcomes

FDA APPROVED fruquintinib (Fruzaqla) over a computer rendering of colorectal cancer.

<乌鸦传媒>New Oral Drug Approved for Metastatic Colorectal Cancer

In phase III trials of pretreated patients, fruquintinib improved survival versus placebo

FDA APPROVED tirzeptide (Zepbound) over a photo of a woman holding an injection pen.

<乌鸦传媒>Tirzepatide Wins FDA Approval for Weight Loss

Drug also gets a new brand name, Zepbound, for its new indication

FDA APPROVED Paradise ultrasound renal denervation system over a computer rendering of the device.

<乌鸦传媒>FDA Approves First Renal Denervation System for Hypertension

Catheter-based technology will finally enter the market with ultrasound-based device

FDA ADCOMM Salvaged blood irradiators over a photo of a blood irradiator.

<乌鸦传媒>FDA Panel Backs High-Risk Designation for Salvaged Blood Irradiators

With Class III designation, sponsors would have to prove safety, efficacy with randomized trials

A photo of eye care products on the shelf of a pharmacy.

<乌鸦传媒>Regulation Gap Persists in OTC Eye Care Products

Poor oversight, sketchy product information endanger public health, experts say

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