Medtronic's Renal Denervation System for Hypertension Splits FDA Panel Once resurrected, is radiofrequency renal denervation heading back to limbo? Aug 24, 2023
FDA Panel Backs ReCor's Renal Denervation System for Hypertension Device-based treatment passes hurdle despite concerns about effectiveness Aug 22, 2023
RSV Vaccine Approved for Use in Pregnancy to Protect Infants Prescribing info has warning about the potential risk for premature birth Aug 22, 2023
Huntington's Disease Chorea Gets New Treatment Thumbs up for the VMAT2 inhibitor valbenazine, FDA says Aug 21, 2023
FDA Advisors' Recommendation on Renal Denervation Hinges on Effectiveness Question Device-based hypertension treatments have only modest BP reductions Aug 21, 2023
Ultra-Rare Immune System Disease Gets First FDA-Approved Treatment Pozelimab reduced hospitalizations, albumin transfusions in CHAPLE disease patients Aug 18, 2023
FDA Grants De Novo Request for Neuromodulatory System for Urge Incontinence Three-fourths of patients had 50% reduction in incontinence at 6 months, 82% at 12 months Aug 18, 2023
From Salad Roulette to Salmonella in Poultry and Peanuts The folly of believing U.S. food is as safe as safe can be Aug 17, 2023
First Therapy Approved for Ultra-Rare Bone Disorder Oral retinoid lands indication for fibrodysplasia ossificans progressiva Aug 16, 2023
FDA OKs First Liver-Directed Treatment for Metastatic Uveal Melanoma Hepzato Kit melphalan delivery system produced objective responses in 36% of patients Aug 15, 2023
Does Kratom Need Tighter Regulation? Efforts to regulate or ban the drug have fizzled, leaving it in purgatory Aug 14, 2023
Is Doctor Pay Too High? NIH Pulls Plug on Misinfo Research; FDA and EPA Butt Heads This past week in healthcare investigations Aug 09, 2023
Second Drug for Geographic Atrophy Gets Green Light From FDA Avacincaptad pegol reduced the rate of disease progression by as much as 35% after 12 months Aug 07, 2023
FDA OKs First Pill for Postpartum Depression In one trial, more than twice as many women achieved remission after 2-week treatment course Aug 04, 2023
Continuation Patents Have Surged, Disrupting Generic Competition, Study Shows Researchers caution that abusing patent laws harms patients, stifles innovation Aug 01, 2023
Sticker Shock: Ophthalmic Bevacizumab Biosimilar Could Drive Up Costs Medicare expenditures could jump 15-30%, with similar increases in patients' out-of-pocket costs Aug 01, 2023
FDA Approves New Frontline Endometrial Cancer Regimen, First in Decades Dostarlimab (Jemperli) approved with chemotherapy for dMMR or MSI-high cancers Jul 31, 2023
FDA Head Robert Califf Battles Misinformation β Sometimes With Fuzzy Facts Often, the misinformation is about misinformation Jul 30, 2023
Impella Devices Recalled After Deaths, Injuries Tied to TAVR Interactions Recall involves new instructions for use without devices needing to be returned Jul 28, 2023
FDA Warns Company Over Amniotic Products Agency says Cell Genuity products should be regulated as a drug Jul 27, 2023
First Treatment for Demodex Blepharitis Wins FDA Approval Lotilaner ophthalmic solution reduced eyelash collarettes, increased mite eradication Jul 26, 2023
DOJ Goes After PA for Amniotic Fluid Injections Prosecutors called shots a "dubious attempt at pain management" Jul 25, 2023
First Treatment Approved for Molluscum Contagiosum Half of patients across two randomized trials had complete clearance of lesions Jul 24, 2023
FDA Strikes at Yet Another Birth Tissue Company Agency sent warning letter to Regenative Labs over its Wharton's jelly product Jul 19, 2023
New Drug Approved for Preventing RSV in Newborns, Tots Nirsevimab indicated for all infants, and for kids up to 2 years at high risk Jul 17, 2023
Registry Enrollment for Alzheimer's Drug Coverage Won't Help Much A minimalist policy for a minimalist treatment Jul 11, 2023
FDA Appears to Mostly Follow Its Drug Advisory Committees' Advice "Pro-approval bias" suggests committees are used to identify barriers to approval, expert argues Jul 07, 2023
Psychedelic Research: Experts React to FDA Draft Guidance Feedback is mostly positive, but concerns arise around two-monitor recommendation Jul 06, 2023
First Dual-Chamber Leadless Pacemaker Approved by FDA System comprises two small leadless pacemakers communicating wirelessly Jul 05, 2023
First Cellular Therapy Approved for Type 1 Diabetes Infusion made from deceased donor pancreatic islet cells Jun 29, 2023
FDA Greenlights New Myasthenia Gravis Drug First therapy approved for anti-AChR-positive and anti-MuSK antibody-positive patients Jun 27, 2023
FDA Staff Weighs 'Alternative' Data on Retinoid for Rare Bone Disorder Challenges of drug development in fibrodysplasia ossificans progressiva on full display Jun 27, 2023
Without Early Detection, Fighting Dementia Is an Uphill Battle A brief assessment in primary care can help identify patients most at risk Jun 27, 2023
First Oral JAK Inhibitor Approved for Severe Alopecia Areata in Teens Ritlecitinib led to 80% scalp coverage at 6 months in nearly a fourth of adolescents and adults Jun 26, 2023
Our Health Systems Aren't Ready for the Full Approval of Lecanemab Screening, administration, and eligibility concerns remain Jun 23, 2023
Controversial Gene Therapy Wins FDA Approval for Duchenne Muscular Dystrophy Sarepta's treatment gets a nod for ambulatory pediatric patients Jun 22, 2023
Another Online SARMs Retailer Gets a Warning From the FDA Warrior Labz SARMS markets several drugs they claim could address weight loss, muscle growth Jun 22, 2023
First SGLT2 Inhibitor Approved for Kids With Type 2 Diabetes Now another oral option other than metformin Jun 21, 2023