<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>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>Is Doctor Pay Too High? NIH Pulls Plug on Misinfo Research; FDA and EPA Butt Headsѻý> This past week in healthcare investigations Aug 09, 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
<ѻý>First Treatment for Demodex Blepharitis Wins FDA Approvalѻý> Lotilaner ophthalmic solution reduced eyelash collarettes, increased mite eradication Jul 26, 2023
<ѻý>DOJ Goes After PA for Amniotic Fluid Injectionsѻý> Prosecutors called shots a "dubious attempt at pain management" Jul 25, 2023
<ѻý>First Treatment Approved for Molluscum Contagiosumѻý> Half of patients across two randomized trials had complete clearance of lesions Jul 24, 2023
<ѻý>FDA Strikes at Yet Another Birth Tissue Companyѻý> Agency sent warning letter to Regenative Labs over its Wharton's jelly product Jul 19, 2023
<ѻý>New Drug Approved for Preventing RSV in Newborns, Totsѻý> Nirsevimab indicated for all infants, and for kids up to 2 years at high risk Jul 17, 2023
<ѻý>Registry Enrollment for Alzheimer's Drug Coverage Won't Help Muchѻý> A minimalist policy for a minimalist treatment Jul 11, 2023
<ѻý>FDA Appears to Mostly Follow Its Drug Advisory Committees' Adviceѻý> "Pro-approval bias" suggests committees are used to identify barriers to approval, expert argues Jul 07, 2023
<ѻý>Alzheimer's Drug Wins Full FDA Approvalѻý> Decision expands lecanemab's Medicare coverage Jul 06, 2023
<ѻý>Psychedelic Research: Experts React to FDA Draft Guidanceѻý> Feedback is mostly positive, but concerns arise around two-monitor recommendation Jul 06, 2023