FDA Staff Voice Serious Concerns About Investigational ALS Cell Therapy Data are "scientifically incomplete" and manufacturing info is "grossly deficient" Sep 25, 2023
The White House Cancer Moonshot Is a Dud We're failing to take simple steps to reduce one of the biggest causes of cancer Sep 22, 2023
FDA Panel: All Thumbs Down for GLP-1 Agonist Implant for Diabetes We haven't seen "the best version of this device," said panel member Sep 22, 2023
FDA Advisors Grapple With Logistical, Ethical Issues of Artificial Womb Technology Further discussion about first-in-human trials is ongoing Sep 20, 2023
FDA Shoots Down Needle-Free EpiPen Alternative, Requests More Data Agency asks drugmaker for a repeat-dose study before approval Sep 20, 2023
Third Time's a Charm for GLP-1 Diabetes Device? FDA Staff Suggest Otherwise. Advisory committee to weigh in on safety concerns with GLP-1 receptor agonist implant Sep 20, 2023
Large Study Eases Fears Over Zantac-Cancer Link In multinational cohort, cancer incidence with pulled drug no different than other H2RAs Sep 19, 2023
FDA Approves JAK Inhibitor That Addresses Anemia in Myelofibrosis In a phase III trial, momelotinib reduced anemia, constitutional symptoms, and splenomegaly Sep 18, 2023
FDA Reviewers Have Concerns About Artificial Womb Trials in Humans The Pediatric Advisory Committee will discuss if data support a safe first-in-human trial Sep 15, 2023
No 'Silver Bullet' for Generic Drug Shortage, House Members Told A total of 301 drugs were in active shortage last year Sep 14, 2023
FDA Panel Reluctantly Backs Patisiran for ATTR Cardiomyopathy Clinical meaningfulness is a different question, however Sep 13, 2023
What It Will Really Take to Restore Trust in the CDC A singular narrative, consistency, and relatability are paramount Sep 13, 2023
FDA Warns Companies About Unapproved Ophthalmic Products Walgreens and CVS among companies accused of marketing products with "heightened risk of harm" Sep 13, 2023
Novel System Snags FDA Approval for Severe Peripheral Arterial Disease Device designed to prevent amputation in chronic limb-threatening ischemia Sep 12, 2023
Stem-Cell Mobilization Booster Wins FDA Approval for Multiple Myeloma Motixafortide plus filgrastim increased adequate harvest rate from 9.5% to 67.5% Sep 11, 2023
FDA OKs Updated COVID Shots New single-strain vaccines will exclusively target the XBB.1.5 Omicron subvariant Sep 11, 2023
How Vital Drug Shortages Happen "Fundamentally, there's something broken in how the market works" Sep 11, 2023 video
FDA Reviewers Say OTC Decongestant Doesn't Work But they acknowledge that taking the only shelf-accessible product off the market raises issues Sep 07, 2023
How to Help Patients Navigate a Newly Complex Vaccine Season The primary message should focus on the importance of the flu, RSV, and COVID vaccines Sep 05, 2023
Antiquated U.S. Laws Governing Methadone Access Must Change One-size-fits-all treatment approaches sometimes fail Aug 31, 2023
FDA Drug Approvals: Let Us See All the Evidence Clinicians and consumers are deprived of the full picture needed for informed decision-making Aug 27, 2023
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
