<ѻý>FDA Clears First Oral Device Treatment for Severe Sleep Apneaѻý> Oral appliances represent an alternative to CPAP and surgical neurostimulation implants Nov 30, 2023
<ѻý>FDA Warns That Philips' CPAP Machines May Overheatѻý> Thermal issues including burns, smoke, fire among reports submitted by DreamStation 2 users Nov 29, 2023
<ѻý>FDA Warns of Rare Life-Threatening Reaction to Anti-Seizure Drugsѻý> Prescribing information changed for levetiracetam, clobazam Nov 28, 2023
<ѻý>FDA Investigating 'Serious Risk' of Malignancy After CAR-T Therapyѻý> Applies to all approved therapies, but benefits still outweigh risks, agency says Nov 28, 2023
<ѻý>FDA Approves First Therapy for Progressive Desmoid Tumorsѻý> Nirogacestat reduced the risk of disease progression or death by 71% in randomized trial Nov 28, 2023
<ѻý>Biden Administration Announces Actions to Strengthen the Drug Supply Chainѻý> Biden will use the Defense Production Act to increase American production of some medications Nov 27, 2023
<ѻý>What to Know About Ongoing Eye Drop Recallsѻý> FDA was spurred into action by a deadly bacterial outbreak earlier this year, advocates say Nov 20, 2023
<ѻý>Drug Candidate for Chronic Cough Rejected by FDA Panelѻý> Gefapixant's benefit not clinically meaningful enough, panelists say Nov 17, 2023
<ѻý>First AKT Inhibitor Approved for Advanced Breast Cancerѻý> Capivasertib plus fulvestrant doubled progression-free survival versus fulvestrant-placebo Nov 17, 2023
<ѻý>Opioid Doc Sentenced; World's First Sickle Cell Gene Tx; FTC Warns Diet Influencersѻý> Health news and commentary from around the Web gathered by ѻý staff Nov 17, 2023
<ѻý>FDA Panel: Tolerating Approval Outliers Would Set 'Dangerous Precedent'ѻý> No easy answers for two drugs for rare lymphoma on long cruise with accelerated approval Nov 16, 2023
<ѻý>First At-Home Test for Chlamydia and Gonorrhea Authorized by FDAѻý> OTC option arrives amid rising cases of the sexually transmitted infections Nov 16, 2023
<ѻý>FDA OKs New Option for Advanced ROS1-Positive Lung Cancerѻý> Drug achieved high response rates in TKI-naive and TKI-pretreated patients Nov 16, 2023
<ѻý>Unclear if Chronic Cough Drug Has Meaningful Benefit, FDA Reviewers Sayѻý> Previously rejected gefapixant will face agency's panel of outside experts on Friday Nov 16, 2023
<ѻý>FDA OKs Product to Thwart Bloodstream Infections During Dialysisѻý> Taurolidine-heparin solution reduced infections by 71% versus heparin alone Nov 15, 2023
<ѻý>Anthrax Guidance Issued; FDA Warns Amazon; AI Deepfakes Challenge Public Healthѻý> Health news and commentary from around the Web gathered by ѻý staff Nov 15, 2023
<ѻý>Lymphoma Drug Copanlisib to Be Pulled From U.S. Marketѻý> Failed confirmatory trial takes down another PI3K inhibitor Nov 14, 2023
<ѻý>Communicating Uncertainty About Drugs Granted Accelerated Approvalѻý> An education gap exists about "the possibility that these drugs might not work," says expert Nov 13, 2023 video
<ѻý>First Treatment Approved for Genetic Clotting Disorderѻý> Adzynma indicated as prophylactic or on-demand enzyme replacement therapy in cTTP Nov 10, 2023
<ѻý>First Chikungunya Vaccine Lands Conditional FDA Approvalѻý> High level of seroprotection, but adverse reactions warrant postmarketing study Nov 10, 2023
<ѻý>Competing Incentives of the FDA's Accelerated Drug Approvalѻý> Experts weigh drug availability against possible suboptimal outcomes Nov 09, 2023 video
<ѻý>New Oral Drug Approved for Metastatic Colorectal Cancerѻý> In phase III trials of pretreated patients, fruquintinib improved survival versus placebo Nov 09, 2023
<ѻý>Tirzepatide Wins FDA Approval for Weight Lossѻý> Drug also gets a new brand name, Zepbound, for its new indication Nov 08, 2023
<ѻý>FDA Approves First Renal Denervation System for Hypertensionѻý> Catheter-based technology will finally enter the market with ultrasound-based device Nov 08, 2023
<ѻý>FDA Panel Backs High-Risk Designation for Salvaged Blood Irradiatorsѻý> With Class III designation, sponsors would have to prove safety, efficacy with randomized trials Nov 07, 2023
<ѻý>Regulation Gap Persists in OTC Eye Care Productsѻý> Poor oversight, sketchy product information endanger public health, experts say Nov 04, 2023
<ѻý>Evidence of Safety, Efficacy for Salvaged Blood Irradiators Lacking, FDA Staff Sayѻý> Devices are aimed at preventing metastasis during surgery Nov 03, 2023
<ѻý>New Option Approved for Erosive Esophagitisѻý> Vonoprazan lands indication for healing and maintenance across all grades of condition Nov 02, 2023
<ѻý>FDA's Revolving Door; 2.4 Million Excess Deaths; Can Anorexia Be 'Terminal'?ѻý> Health news and commentary from around the Web gathered by ѻý staff Nov 02, 2023
<ѻý>Stelara Biosimilar OK'd With Interchangeabilityѻý> But patent settlement may keep new product off market until 2025 Nov 01, 2023
<ѻý>Potential Cure for Sickle Cell Clears Hurdle for Approvalѻý> FDA advisors suggest the benefits of gene therapy outweigh risks of off-target editing Oct 31, 2023
<ѻý>FDA Outlines Rules for Telling Clinicians About Unapproved Uses of Drugs, Devicesѻý> Draft guidance explains what doesn't qualify as "scientifically sound" information Oct 31, 2023
<ѻý>FDA Reviewers Question Safety of Sickle Cell Gene Therapyѻý> Efficacy results "strongly positive," but unintended off-target effects a question Oct 30, 2023
<ѻý>FDA OKs First Drug for Nasopharyngeal Carcinomaѻý> Toripalimab approved in combination with first-line chemo, and as monotherapy after progression Oct 30, 2023
<ѻý>What If Trial Participants Knew Their Contributions Were for Naught?ѻý> A call for enforcing trial reporting requirements Oct 28, 2023
<ѻý>Novel Drug OK'd for Ulcerative Colitisѻý> First agent to target p19 subunit of IL-23 Oct 27, 2023
<ѻý>Soap to Fight Skin Cancer; $1,000 Early Cancer Detection Test; FDA Approval in MDSѻý> News, features, and commentary about cancer-related issues Oct 27, 2023
<ѻý>Novel Corticosteroid Approved for Rare Diseaseѻý> Vamorolone gets a nod from FDA for Duchenne muscular dystrophy Oct 27, 2023
<ѻý>Probiotics for Preterm Infants Could Pose Serious Danger, FDA Warnsѻý> Abbott, Infinant Health sent warning letters about their products Oct 26, 2023
<ѻý>IG Live October 23: Life in the Fast Lane With FDA's Accelerated Approvalsѻý> Experts share their perspectives on the increasingly controversial FDA pathway Oct 19, 2023