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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.

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 木瓜直播 staff

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 木瓜直播 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

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

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

Opioid Doc Sentenced; World's First Sickle Cell Gene Tx; FTC Warns Diet Influencers

Health news and commentary from around the Web gathered by 木瓜直播 staff

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

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 木瓜直播 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

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

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.

First Chikungunya Vaccine Lands Conditional FDA Approval

High level of seroprotection, but adverse reactions warrant postmarketing study

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.

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.

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.

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.

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.

Regulation Gap Persists in OTC Eye Care Products

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

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

Evidence of Safety, Efficacy for Salvaged Blood Irradiators Lacking, FDA Staff Say

Devices are aimed at preventing metastasis during surgery

FDA approved vonoprazan (Voquezna) over a computer rendering of pills traveling down an inflamed esophagus.

New Option Approved for Erosive Esophagitis

Vonoprazan lands indication for healing and maintenance across all grades of condition

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

FDA's Revolving Door; 2.4 Million Excess Deaths; Can Anorexia Be 'Terminal'?

Health news and commentary from around the Web gathered by 木瓜直播 staff

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