<ѻýҕl>A Closer Look at the Approval of CRISPR/Cas9 Gene Therapy for Sickle Cell Diseaseѻýҕl> This landmark event brings up broader considerations and implications for other diseases Dec 11, 2023
<ѻýҕl>FDA Inspections of Foreign Drug Manufacturers Haven't Bounced Back After Pandemicѻýҕl> Overseas inspections "well below" pre-pandemic surveillance Dec 08, 2023
<ѻýҕl>Milestone Gene Therapies for Sickle Cell Disease Greenlit by FDAѻýҕl> Casgevy and Lyfgenia approved for one-time treatment of sickle cell disease Dec 08, 2023
<ѻýҕl>FDA Clears First At-Home Kit for Artificial Inseminationѻýҕl> Intravaginal device was deemed "substantially equivalent" to clinically used intrauterine device Dec 07, 2023
<ѻýҕl>FDA Approves Oral Factor B Inhibitor for Paroxysmal Nocturnal Hemoglobinuriaѻýҕl> Iptacopan tops C5 Inhibitors for sustained hemoglobin levels, eliminating need for transfusion Dec 06, 2023
<ѻýҕl>Jamie Foxx's Health Scare; 23andMe Hacked; Decongestant Probe Announcedѻýҕl> Health news and commentary from around the Web gathered by ѻýҕl staff Dec 05, 2023
<ѻýҕl>Don't Neglect Tobacco Use in People Experiencing Homelessnessѻýҕl> Cessation programs can save lives and improve financial stability Dec 04, 2023
<ѻýҕl>Gaming the Patent System Can Keep Biosimilars Off the Market for Decadesѻýҕl> Sean Tu, PhD, JD, explains trade secret laws and patent laws for biologics Dec 04, 2023 video
<ѻýҕl>Non-Covalent BTK Inhibitor Approved for CLLѻýҕl> Response rates with pirtobrutinib reached 72% in heavily pretreated patient population Dec 04, 2023
<ѻýҕl>FDA Clears First Oral Device Treatment for Severe Sleep Apneaѻýҕl> Oral appliances represent an alternative to CPAP and surgical neurostimulation implants Nov 30, 2023
<ѻýҕl>FDA Warns That Philips' CPAP Machines May Overheatѻýҕl> Thermal issues including burns, smoke, fire among reports submitted by DreamStation 2 users Nov 29, 2023
<ѻýҕl>FDA Warns of Rare Life-Threatening Reaction to Anti-Seizure Drugsѻýҕl> Prescribing information changed for levetiracetam, clobazam Nov 28, 2023
<ѻýҕl>FDA Investigating 'Serious Risk' of Malignancy After CAR-T Therapyѻýҕl> Applies to all approved therapies, but benefits still outweigh risks, agency says Nov 28, 2023
<ѻýҕl>FDA Approves First Therapy for Progressive Desmoid Tumorsѻýҕl> Nirogacestat reduced the risk of disease progression or death by 71% in randomized trial Nov 28, 2023
<ѻýҕl>Biden Administration Announces Actions to Strengthen the Drug Supply Chainѻýҕl> Biden will use the Defense Production Act to increase American production of some medications Nov 27, 2023
<ѻýҕl>Devastating Medication Error; FDA's Recall Weakness; Insurers Break State Lawsѻýҕl> This past week in healthcare investigations Nov 22, 2023
<ѻýҕl>What to Know About Ongoing Eye Drop Recallsѻýҕl> FDA was spurred into action by a deadly bacterial outbreak earlier this year, advocates say Nov 20, 2023
<ѻýҕl>Drug Candidate for Chronic Cough Rejected by FDA Panelѻýҕl> Gefapixant's benefit not clinically meaningful enough, panelists say Nov 17, 2023
<ѻýҕl>First AKT Inhibitor Approved for Advanced Breast Cancerѻýҕl> Capivasertib plus fulvestrant doubled progression-free survival versus fulvestrant-placebo Nov 17, 2023
<ѻýҕl>FDA Panel: Tolerating Approval Outliers Would Set 'Dangerous Precedent'ѻýҕl> No easy answers for two drugs for rare lymphoma on long cruise with accelerated approval Nov 16, 2023
<ѻýҕl>What to Know About Lead Toxicity and Kids' Applesauceѻýҕl> Hospitalization for acute lead toxicity can start at 45 mcg/dL Nov 16, 2023
<ѻýҕl>First At-Home Test for Chlamydia and Gonorrhea Authorized by FDAѻýҕl> OTC option arrives amid rising cases of the sexually transmitted infections Nov 16, 2023
<ѻýҕl>FDA OKs New Option for Advanced ROS1-Positive Lung Cancerѻýҕl> Drug achieved high response rates in TKI-naive and TKI-pretreated patients Nov 16, 2023
<ѻýҕl>Unclear if Chronic Cough Drug Has Meaningful Benefit, FDA Reviewers Sayѻýҕl> Previously rejected gefapixant will face agency's panel of outside experts on Friday Nov 16, 2023
<ѻýҕl>FDA OKs Product to Thwart Bloodstream Infections During Dialysisѻýҕl> Taurolidine-heparin solution reduced infections by 71% versus heparin alone Nov 15, 2023
<ѻýҕl>Anthrax Guidance Issued; FDA Warns Amazon; AI Deepfakes Challenge Public Healthѻýҕl> Health news and commentary from around the Web gathered by ѻýҕl staff Nov 15, 2023
<ѻýҕl>Lymphoma Drug Copanlisib to Be Pulled From U.S. Marketѻýҕl> Failed confirmatory trial takes down another PI3K inhibitor Nov 14, 2023
<ѻýҕl>Communicating Uncertainty About Drugs Granted Accelerated Approvalѻýҕl> An education gap exists about "the possibility that these drugs might not work," says expert Nov 13, 2023 video
<ѻýҕl>First Treatment Approved for Genetic Clotting Disorderѻýҕl> Adzynma indicated as prophylactic or on-demand enzyme replacement therapy in cTTP Nov 10, 2023
<ѻýҕl>First Chikungunya Vaccine Lands Conditional FDA Approvalѻýҕl> High level of seroprotection, but adverse reactions warrant postmarketing study Nov 10, 2023
<ѻýҕl>Competing Incentives of the FDA's Accelerated Drug Approvalѻýҕl> Experts weigh drug availability against possible suboptimal outcomes Nov 09, 2023 video
<ѻýҕl>New Oral Drug Approved for Metastatic Colorectal Cancerѻýҕl> In phase III trials of pretreated patients, fruquintinib improved survival versus placebo Nov 09, 2023
<ѻýҕl>Tirzepatide Wins FDA Approval for Weight Lossѻýҕl> Drug also gets a new brand name, Zepbound, for its new indication Nov 08, 2023
<ѻýҕl>FDA Approves First Renal Denervation System for Hypertensionѻýҕl> Catheter-based technology will finally enter the market with ultrasound-based device Nov 08, 2023
<ѻýҕl>FDA Panel Backs High-Risk Designation for Salvaged Blood Irradiatorsѻýҕl> With Class III designation, sponsors would have to prove safety, efficacy with randomized trials Nov 07, 2023
<ѻýҕl>Regulation Gap Persists in OTC Eye Care Productsѻýҕl> Poor oversight, sketchy product information endanger public health, experts say Nov 04, 2023
<ѻýҕl>Evidence of Safety, Efficacy for Salvaged Blood Irradiators Lacking, FDA Staff Sayѻýҕl> Devices are aimed at preventing metastasis during surgery Nov 03, 2023
<ѻýҕl>New Option Approved for Erosive Esophagitisѻýҕl> Vonoprazan lands indication for healing and maintenance across all grades of condition Nov 02, 2023
<ѻýҕl>FDA's Revolving Door; 2.4 Million Excess Deaths; Can Anorexia Be 'Terminal'?ѻýҕl> Health news and commentary from around the Web gathered by ѻýҕl staff Nov 02, 2023
<ѻýҕl>Stelara Biosimilar OK'd With Interchangeabilityѻýҕl> But patent settlement may keep new product off market until 2025 Nov 01, 2023