<ѻýҕl>FDA Allows Lower Risk Designation for Snuff Productѻýҕl> The brand joins a limited few granted modified risk tobacco claims Mar 16, 2023
<ѻýҕl>CDC, FDA Heads Fire Back at Ladapo Letterѻýҕl> Califf and Walensky say Florida Surgeon General's VAERS analysis is "incorrect, misleading" Mar 13, 2023
<ѻýҕl>FDA Panel Endorses New First-Line Lymphoma Regimenѻýҕl> POLARIX trial supports a favorable risk-benefit profile for polatuzumab vedotin, ODAC members say Mar 10, 2023
<ѻýҕl>First Bimodal Neuromodulation Device for Tinnitus Gets FDA Nodѻýҕl> Ringing ears may get relief with sound and tongue stimulation Mar 08, 2023
<ѻýҕl>Only Drug to Prevent Preterm Birth Set to Leave the Marketѻýҕl> Decision follows FDA advisory committee recommendation for withdrawal Mar 08, 2023
<ѻýҕl>FDA Not Quite Sold on Polivy in Frontline Large B-Cell Lymphoma Regimenѻýҕl> Ahead of ODAC meeting, agency reviewers suggest modest PFS results in POLARIX "raise uncertainty" Mar 07, 2023
<ѻýҕl>FDA Mandate on Acetaminophen-Opioid Combinations Appeared Effectiveѻýҕl> Hospitalizations for liver toxicity declined after FDA limited acetaminophen dose Mar 07, 2023
<ѻýҕl>First Treatment Approved for Rare Neurodegenerative Disorderѻýҕl> Omaveloxolone gets FDA nod for Friedreich's ataxia Mar 01, 2023
<ѻýҕl>Omecamtiv Mecarbil for Heart Failure Turned Down by FDAѻýҕl> End of the road for cardiac myosin activator Mar 01, 2023
<ѻýҕl>FDA Issues Import Alert on 'Tranq' Drug Xylazineѻýҕl> Drug will be under added scrutiny to make sure it's for "legitimate veterinary use," agency says Feb 28, 2023
<ѻýҕl>A Ban on the Abortion Drug Mifepristone Is Loomingѻýҕl> A Texas lawsuit may be disastrous for effective abortion access and FDA's authority Feb 23, 2023
<ѻýҕl>Over-the-Counter Naloxone Has the Power to Save Livesѻýҕl> But removing barriers to access is an essential next step Feb 23, 2023
<ѻýҕl>Alzheimer's Data Faked? Docs 'Groomed' to Overuse Devices; Orphan Drug Fightѻýҕl> This past week in healthcare investigations Feb 22, 2023
<ѻýҕl>FDA Approves First Treatment for Geographic Atrophy Secondary to AMDѻýҕl> Pegcetacoplan reduced GA lesion growth by 22% over 24 months versus sham injections Feb 18, 2023
<ѻýҕl>FDA OKs First Therapy for Alpha-Mannosidosisѻýҕl> Velmanase alfa approved for treating non-CNS manifestations of progressive, inherited disease Feb 17, 2023
<ѻýҕl>Proposed User Instructions for OTC Narcan Has FDA Concernedѻýҕl> In emergency setting, proper use and administration by consumer is "essential," says agency staff Feb 14, 2023
<ѻýҕl>What Happened to the Monoclonal Antibodies for COVID-19?ѻýҕl> Losing focus on monoclonals means neglecting those who need them most: the immunocompromised Feb 13, 2023 video
<ѻýҕl>FDA Warns on Use of Hospira Drug in Kids Due to 'Unsafe' Aluminum Levelsѻýҕl> Agency cites risk for aluminum toxicity in infants Feb 10, 2023
<ѻýҕl>FDA Has Concerns on 'Unprecedented' Plan for Dostarlimab in Rectal Cancerѻýҕl> Panel will discuss if single-arm trials and proposed endpoints are adequate to support approval Feb 08, 2023
<ѻýҕl>Do Weight-Loss Startups Have a Future?ѻýҕl> Here are my predictions for the industry Feb 07, 2023
<ѻýҕl>Ketamine Clinics Are Jumping Ahead of the Evidenceѻýҕl> New mental health treatments must be approached with caution Feb 05, 2023
<ѻýҕl>How Patent Thickets Keep Cheaper Drugs Off the Marketѻýҕl> "We're transferring a huge amount of wealth from the public to drug companies," says S. Sean Tu Feb 03, 2023 video
<ѻýҕl>What Doctors Should Know About Xylazine in Fentanylѻýҕl> Naloxone still works but additional support may be needed; wound care a challenge Feb 01, 2023
<ѻýҕl>FDA Greenlights First Drug for ESR1-Mutated Breast Cancerѻýҕl> Elacestrant almost doubled PFS versus standard endocrine therapy in advanced ER+/HER2- disease Jan 30, 2023
<ѻýҕl>Doc Delivered Deadly Epidural; Hotze's Conspiracy Theory; Docs Slam Wegovy Storyѻýҕl> This past week in healthcare investigations Jan 25, 2023
<ѻýҕl>FDA, NIH Must Penalize Researchers Who Don't Report Trial Results, House Member Saysѻýҕl> Many with NIH grants don't follow reporting rules, get funded again anyway, says Rep. Pallone Jan 20, 2023
<ѻýҕl>CDC, FDA Flag Early Signal of Stroke Risk With Bivalent COVID Vaccineѻýҕl> One surveillance system detects potential link in seniors, yet multiple others show none Jan 13, 2023
<ѻýҕl>Legal Loophole Lets Faulty Devices Maintain Their Legacyѻýҕl> Harlan Krumholz on how devices subject to Class I recalls are used as predicates for new devices Jan 11, 2023 video
<ѻýҕl>Alzheimer's Drug Lecanemab Wins FDA Approvalѻýҕl> Anti-amyloid showed modest benefit in phase III trial, but was linked to adverse events Jan 06, 2023
<ѻýҕl>Abortion Pill Can Be Dispensed in Retail Pharmacies, FDA Saysѻýҕl> Decision allows patients to pick up mifepristone at brick-and-mortar locations Jan 04, 2023
<ѻýҕl>Crystal Ball Cloudy for PI3K Inhibitors' Future in Hematologyѻýҕl> After a year of negative news, some caution about throwing out the baby with the bath water Jan 02, 2023
<ѻýҕl>Anti-CD20 Agent Gains Approval for Multiple Sclerosisѻýҕl> FDA greenlights ublituximab for relapsing MS Dec 29, 2022
<ѻýҕl>Wegovy OK'd for Teens With Obesityѻýҕl> New indication for popular weight-loss injectable Dec 29, 2022
<ѻýҕl>No, the Baby Formula Shortage Still Isn't Overѻýҕl> Experts say regulatory changes treat symptoms but not all causes of the formula crisis Dec 28, 2022
<ѻýҕl>Families Push Research Forward in Rare Diseasesѻýҕl> The field has a unique funding model. While fruitful, some question if it needs to change. Dec 26, 2022
<ѻýҕl>FDA Approves First Gene Therapy for Non-Muscle-Invasive Bladder Cancerѻýҕl> Half of patients achieved complete responses with adenoviral vector-based product Dec 16, 2022
<ѻýҕl>'Constant Turmoil' at FDA Makes Our Food Less Safeѻýҕl> Reflections on a new report about the agency's Human Foods Program Dec 16, 2022
<ѻýҕl>Why Does Makena Remain on the Market?ѻýҕl> Misguided equity claims do not resolve issues with the accelerated approval program Dec 11, 2022
<ѻýҕl>New IDH1 Inhibitor Wins FDA Approval for Acute Myeloid Leukemiaѻýҕl> Olutasidenib led to a 35% response rate in a study of adults with previously treated AML Dec 02, 2022
<ѻýҕl>FDA Greenlights First Fecal Microbiota Productѻýҕl> Rebyota approved for preventing recurrence of C. difficile infection Dec 01, 2022