<ѻý>FDA OKs First Cellular Therapy for Melanomaѻý> Lifileucel approved as treatment for advanced melanoma after anti-PD-1 and targeted therapy Feb 16, 2024
<ѻý>First Drug OK'd for Reducing Allergic Reactions From Multiple Foodsѻý> 68% of patients who received omalizumab tolerated a single dose of peanut after 16-20 weeks Feb 16, 2024
<ѻý>Tepotinib Gains Full Approval for Metastatic NSCLCѻý> Agency converts accelerated approval for subset with MET exon 14 mutations Feb 16, 2024
<ѻý>Lawmakers Clash Over COVID Vaccine Safety at House Hearingѻý> Purpose of CDC's VAERS reporting system debated Feb 15, 2024
<ѻý>COVID's Latest Adaptation: It Has Lulled Us to Sleepѻý> My doctor's refusal to prescribe "just-in-case" Paxlovid speaks volumes Feb 15, 2024
<ѻý>FDA Approves First Drug for Severe Frostbiteѻý> Vasodilator iloprost significantly cut the risk of amputations in trial Feb 14, 2024
<ѻý>FDA Advisors Nearly All Aboard the TriClip Train for Tricuspid Regurgitationѻý> Committee voted 13-1 that the benefits of the TEER device outweigh the risks in certain patients Feb 14, 2024
<ѻý>New First-Line Option for Pancreatic Cancer Approvedѻý> Liposomal irinotecan-based regimen gets FDA greenlight for metastatic disease Feb 13, 2024
<ѻý>FDA Reviewers Skeptical on TriClip for Tricuspid Regurgitationѻý> Tricuspid valve repair system is up for advisory committee scrutiny on Tuesday Feb 12, 2024
<ѻý>Sleep Apnea Smartwatch Feature Gets FDA Authorizationѻý> Software is first of its kind to receive agency greenlight, set to roll out this year Feb 12, 2024
<ѻý>FDA Approves First Oral Option for Eosinophilic Esophagitisѻý> Fixed-duration course of corticosteroid indicated for patients 11 years and up Feb 12, 2024
<ѻý>Phenylephrine Sales Steady Before FDA Panel Called It Ineffectiveѻý> But reformulation of products containing OTC "decongestant" could affect the supply chain Feb 09, 2024
<ѻý>Treating the Tsetse's Curseѻý> A drug called fexinidazole deserves a heart-felt shout-out Feb 09, 2024
<ѻý>Publisher Retracts Three Abortion Studiesѻý> Two of the studies were cited by a federal judge in the case against the abortion pill Feb 08, 2024
<ѻý>Resmetirom Poised to Become First NASH Treatmentѻý> Phase III study demonstrated drug is effective in resolving NASH and improving liver fibrosis Feb 07, 2024
<ѻý>USMLE Finds Pattern of Suspicious Results From Nepalѻý> Impacted examinees have had step 1, 2, and/or 3 examinations invalidated Feb 07, 2024
<ѻý>FDA Panel Mulls Which Devices Are Critical in a Public Health Emergencyѻý> "If we have a thermonuclear war, all I need is a scalpel," one panel member said Feb 06, 2024
<ѻý>Medicine or Candy? Let's Reevaluate the Vitamins We Offer to Kidsѻý> Children should give standard pills a try before turning to alternatives Feb 06, 2024
<ѻý>What Exactly Is a 'Critical' Medical Device? FDA Seeks Advice on the Issueѻý> Advisory panel to consider which devices should be on a list for shortage notifications Feb 05, 2024
<ѻý>Ketamine Therapy for Mental Health a ‘Wild West’ for Doctors and Patientsѻý> For some patients it's a "light at the end of the tunnel" Feb 04, 2024
<ѻý>FDA Advisory Panel Generally Pleased With Pulse Oximetry Clinical Trial Proposalѻý> But some questions arose regarding number of participants, permissible variance in measurements Feb 03, 2024
<ѻý>First Transcatheter Tricuspid Regurgitation Treatment Approvedѻý> FDA greenlights system for severe cases cleared by the heart team Feb 02, 2024
<ѻý>U.S. Officials Call for More Programs, Education to Improve Diets in Americaѻý> More research on "gut-brain axis" is also needed Feb 02, 2024
<ѻý>Pulse Oximeters Once Again in the Spotlight at FDAѻý> Advisory panel to discuss how to improve device accuracy for patients with darker skin Jan 31, 2024
<ѻý>Controversial Alzheimer's Drug Abandonedѻý> Biogen will stop developing and selling aducanumab Jan 31, 2024
<ѻý>FDA OKs Farapulse Pulsed Field Ablation System for Intermittent Afibѻý> Second catheter-based system approved for paroxysmal Afib Jan 31, 2024
<ѻý>Miracle Cures: Conspiracy Theories Are Fueling a New Age of Unproven Treatmentsѻý> Social media and online skepticism feed fears about traditional care Jan 31, 2024
<ѻý>Penis-Pump Company Chided by FDAѻý> The agency is not enthused by the company's clitoral claims either Jan 29, 2024
<ѻý>Kate Middleton Discharged; Philips to Halt Apnea Device Sales; Pet Dragon Warningѻý> Health news and commentary from around the Web gathered by ѻý staff Jan 29, 2024
<ѻý>How Much Do Physicians Really Know About FDA Drug and Device Regulation?ѻý> More education is clearly needed Jan 28, 2024
<ѻý>When a Revolutionary Cancer Treatment Causes Cancerѻý> The potential benefits of CAR T-cell therapies still far outweigh the risks Jan 27, 2024
<ѻý>CAR-T Investigation: FDA Leaders Detail Decision on Cancer Risk Warningѻý> Post-treatment cases grow to 22 since products' initial approvals Jan 24, 2024
<ѻý>FDA Calls for New Boxed Warning on All CAR-T Productsѻý> Most serious warning would alert patients, providers on potential risk for secondary malignancies Jan 23, 2024
<ѻý>New FDA Boxed Warning; College Shaken by Suicides; More Get Flu Shot Than COVID Vaxѻý> Health news and commentary from around the Web gathered by ѻý staff Jan 23, 2024
<ѻý>FDA Warns Exosome Maker for Marketing Outside Its INDѻý> Agency also raises concern about a potentially contaminated product batch Jan 22, 2024
<ѻý>The Healthcare Landscape Is Changing. Our Regulatory Practices Should Too.ѻý> Closer collaboration between FDA and CMS is the need of the hour Jan 22, 2024
<ѻý>Physicians Don't Always Understand the FDA Approval Process, Survey Findsѻý> Most preferred two or more randomized trials as evidence required for approval Jan 19, 2024
<ѻý>Anti-Tobacco Activists Hold 'Menthol Funeral' in Washingtonѻý> Speakers urge Biden to release long-delayed final rule banning menthol-flavored tobacco products Jan 18, 2024
<ѻý>King Charles III's Surgery; COVID Timeline Doubted; FDA Approvals Hit Highѻý> Health news and commentary from around the Web gathered by ѻý staff Jan 18, 2024
<ѻý>FDA Clears AI-Powered Non-Invasive Skin Cancer Detectorѻý> Intended for use in primary care, handheld device is first of its kind Jan 17, 2024