<ѻý>FDA Advisors Grapple With Logistical, Ethical Issues of Artificial Womb Technologyѻý> Further discussion about first-in-human trials is ongoing Sep 20, 2023
<ѻý>FDA Shoots Down Needle-Free EpiPen Alternative, Requests More Dataѻý> Agency asks drugmaker for a repeat-dose study before approval Sep 20, 2023
<ѻý>Third Time's a Charm for GLP-1 Diabetes Device? FDA Staff Suggest Otherwise.ѻý> Advisory committee to weigh in on safety concerns with GLP-1 receptor agonist implant Sep 20, 2023
<ѻý>Large Study Eases Fears Over Zantac-Cancer Linkѻý> In multinational cohort, cancer incidence with pulled drug no different than other H2RAs Sep 19, 2023
<ѻý>FDA Approves JAK Inhibitor That Addresses Anemia in Myelofibrosisѻý> In a phase III trial, momelotinib reduced anemia, constitutional symptoms, and splenomegaly Sep 18, 2023
<ѻý>FDA Reviewers Have Concerns About Artificial Womb Trials in Humansѻý> The Pediatric Advisory Committee will discuss if data support a safe first-in-human trial Sep 15, 2023
<ѻý>No 'Silver Bullet' for Generic Drug Shortage, House Members Toldѻý> A total of 301 drugs were in active shortage last year Sep 14, 2023
<ѻý>FDA Panel Reluctantly Backs Patisiran for ATTR Cardiomyopathyѻý> Clinical meaningfulness is a different question, however Sep 13, 2023
<ѻý>What It Will Really Take to Restore Trust in the CDCѻý> A singular narrative, consistency, and relatability are paramount Sep 13, 2023
<ѻý>FDA Warns Companies About Unapproved Ophthalmic Productsѻý> Walgreens and CVS among companies accused of marketing products with "heightened risk of harm" Sep 13, 2023
<ѻý>FDA Panel Favors Dropping OTC Decongestantѻý> Unanimous vote that the drug is ineffective Sep 12, 2023
<ѻý>Novel System Snags FDA Approval for Severe Peripheral Arterial Diseaseѻý> Device designed to prevent amputation in chronic limb-threatening ischemia Sep 12, 2023
<ѻý>Stem-Cell Mobilization Booster Wins FDA Approval for Multiple Myelomaѻý> Motixafortide plus filgrastim increased adequate harvest rate from 9.5% to 67.5% Sep 11, 2023
<ѻý>FDA OKs Updated COVID Shotsѻý> New single-strain vaccines will exclusively target the XBB.1.5 Omicron subvariant Sep 11, 2023
<ѻý>How Vital Drug Shortages Happenѻý> "Fundamentally, there's something broken in how the market works" Sep 11, 2023 video
<ѻý>FDA Reviewers Say OTC Decongestant Doesn't Workѻý> But they acknowledge that taking the only shelf-accessible product off the market raises issues Sep 07, 2023
<ѻý>Ivermectin Suit Revived; Curbing Fentanyl Deaths in Kids; Medicare Spending Plateauѻý> This past week in healthcare investigations Sep 06, 2023
<ѻý>What Changed FDA's Mind About Ilaris for Gout?ѻý> Approval comes after previous rejections Sep 05, 2023
<ѻý>How to Help Patients Navigate a Newly Complex Vaccine Seasonѻý> The primary message should focus on the importance of the flu, RSV, and COVID vaccines Sep 05, 2023
<ѻý>Antiquated U.S. Laws Governing Methadone Access Must Changeѻý> One-size-fits-all treatment approaches sometimes fail Aug 31, 2023
<ѻý>FDA Drug Approvals: Let Us See All the Evidenceѻý> Clinicians and consumers are deprived of the full picture needed for informed decision-making Aug 27, 2023
<ѻý>Medtronic's Renal Denervation System for Hypertension Splits FDA Panelѻý> Once resurrected, is radiofrequency renal denervation heading back to limbo? Aug 24, 2023
<ѻý>FDA Panel Backs ReCor's Renal Denervation System for Hypertensionѻý> Device-based treatment passes hurdle despite concerns about effectiveness Aug 22, 2023
<ѻý>RSV Vaccine Approved for Use in Pregnancy to Protect Infantsѻý> Prescribing info has warning about the potential risk for premature birth Aug 22, 2023
<ѻý>Huntington's Disease Chorea Gets New Treatmentѻý> Thumbs up for the VMAT2 inhibitor valbenazine, FDA says Aug 21, 2023
<ѻý>FDA Advisors' Recommendation on Renal Denervation Hinges on Effectiveness Questionѻý> Device-based hypertension treatments have only modest BP reductions Aug 21, 2023
<ѻý>Ultra-Rare Immune System Disease Gets First FDA-Approved Treatmentѻý> Pozelimab reduced hospitalizations, albumin transfusions in CHAPLE disease patients Aug 18, 2023
<ѻý>FDA Grants De Novo Request for Neuromodulatory System for Urge Incontinenceѻý> Three-fourths of patients had 50% reduction in incontinence at 6 months, 82% at 12 months Aug 18, 2023
<ѻý>From Salad Roulette to Salmonella in Poultry and Peanutsѻý> The folly of believing U.S. food is as safe as safe can be Aug 17, 2023
<ѻý>First Therapy Approved for Ultra-Rare Bone Disorderѻý> Oral retinoid lands indication for fibrodysplasia ossificans progressiva Aug 16, 2023
<ѻý>FDA OKs First Liver-Directed Treatment for Metastatic Uveal Melanomaѻý> Hepzato Kit melphalan delivery system produced objective responses in 36% of patients Aug 15, 2023
<ѻý>Does Kratom Need Tighter Regulation?ѻý> Efforts to regulate or ban the drug have fizzled, leaving it in purgatory Aug 14, 2023
<ѻý>Second Drug for Geographic Atrophy Gets Green Light From FDAѻý> Avacincaptad pegol reduced the rate of disease progression by as much as 35% after 12 months Aug 07, 2023
<ѻý>FDA OKs First Pill for Postpartum Depressionѻý> In one trial, more than twice as many women achieved remission after 2-week treatment course Aug 04, 2023
<ѻý>Continuation Patents Have Surged, Disrupting Generic Competition, Study Showsѻý> Researchers caution that abusing patent laws harms patients, stifles innovation Aug 01, 2023
<ѻý>Sticker Shock: Ophthalmic Bevacizumab Biosimilar Could Drive Up Costsѻý> Medicare expenditures could jump 15-30%, with similar increases in patients' out-of-pocket costs Aug 01, 2023
<ѻý>FDA Approves New Frontline Endometrial Cancer Regimen, First in Decadesѻý> Dostarlimab (Jemperli) approved with chemotherapy for dMMR or MSI-high cancers Jul 31, 2023
<ѻý>FDA Head Robert Califf Battles Misinformation — Sometimes With Fuzzy Factsѻý> Often, the misinformation is about misinformation Jul 30, 2023
<ѻý>Impella Devices Recalled After Deaths, Injuries Tied to TAVR Interactionsѻý> Recall involves new instructions for use without devices needing to be returned Jul 28, 2023
<ѻý>FDA Warns Company Over Amniotic Productsѻý> Agency says Cell Genuity products should be regulated as a drug Jul 27, 2023