<ѻý>Over-the-Counter Naloxone Has the Power to Save Livesѻý> But removing barriers to access is an essential next step Feb 23, 2023
<ѻý>Alzheimer's Data Faked? Docs 'Groomed' to Overuse Devices; Orphan Drug Fightѻý> This past week in healthcare investigations Feb 22, 2023
<ѻý>FDA Approves First Treatment for Geographic Atrophy Secondary to AMDѻý> Pegcetacoplan reduced GA lesion growth by 22% over 24 months versus sham injections Feb 18, 2023
<ѻý>FDA OKs First Therapy for Alpha-Mannosidosisѻý> Velmanase alfa approved for treating non-CNS manifestations of progressive, inherited disease Feb 17, 2023
<ѻý>Proposed User Instructions for OTC Narcan Has FDA Concernedѻý> In emergency setting, proper use and administration by consumer is "essential," says agency staff Feb 14, 2023
<ѻý>What Happened to the Monoclonal Antibodies for COVID-19?ѻý> Losing focus on monoclonals means neglecting those who need them most: the immunocompromised Feb 13, 2023 video
<ѻý>FDA Warns on Use of Hospira Drug in Kids Due to 'Unsafe' Aluminum Levelsѻý> Agency cites risk for aluminum toxicity in infants Feb 10, 2023
<ѻý>FDA Has Concerns on 'Unprecedented' Plan for Dostarlimab in Rectal Cancerѻý> Panel will discuss if single-arm trials and proposed endpoints are adequate to support approval Feb 08, 2023
<ѻý>How Patent Thickets Keep Cheaper Drugs Off the Marketѻý> "We're transferring a huge amount of wealth from the public to drug companies," says S. Sean Tu Feb 03, 2023 video
<ѻý>What Doctors Should Know About Xylazine in Fentanylѻý> Naloxone still works but additional support may be needed; wound care a challenge Feb 01, 2023
<ѻý>FDA Greenlights First Drug for ESR1-Mutated Breast Cancerѻý> Elacestrant almost doubled PFS versus standard endocrine therapy in advanced ER+/HER2- disease Jan 30, 2023
<ѻý>Doc Delivered Deadly Epidural; Hotze's Conspiracy Theory; Docs Slam Wegovy Storyѻý> This past week in healthcare investigations Jan 25, 2023
<ѻý>FDA, NIH Must Penalize Researchers Who Don't Report Trial Results, House Member Saysѻý> Many with NIH grants don't follow reporting rules, get funded again anyway, says Rep. Pallone Jan 20, 2023
<ѻý>CDC, FDA Flag Early Signal of Stroke Risk With Bivalent COVID Vaccineѻý> One surveillance system detects potential link in seniors, yet multiple others show none Jan 13, 2023
<ѻý>Legal Loophole Lets Faulty Devices Maintain Their Legacyѻý> Harlan Krumholz on how devices subject to Class I recalls are used as predicates for new devices Jan 11, 2023 video
<ѻý>Alzheimer's Drug Lecanemab Wins FDA Approvalѻý> Anti-amyloid showed modest benefit in phase III trial, but was linked to adverse events Jan 06, 2023
<ѻý>Abortion Pill Can Be Dispensed in Retail Pharmacies, FDA Saysѻý> Decision allows patients to pick up mifepristone at brick-and-mortar locations Jan 04, 2023
<ѻý>Crystal Ball Cloudy for PI3K Inhibitors' Future in Hematologyѻý> After a year of negative news, some caution about throwing out the baby with the bath water Jan 02, 2023
<ѻý>Anti-CD20 Agent Gains Approval for Multiple Sclerosisѻý> FDA greenlights ublituximab for relapsing MS Dec 29, 2022
<ѻý>Wegovy OK'd for Teens With Obesityѻý> New indication for popular weight-loss injectable Dec 29, 2022
<ѻý>No, the Baby Formula Shortage Still Isn't Overѻý> Experts say regulatory changes treat symptoms but not all causes of the formula crisis Dec 28, 2022
<ѻý>Families Push Research Forward in Rare Diseasesѻý> The field has a unique funding model. While fruitful, some question if it needs to change. Dec 26, 2022
<ѻý>FDA Approves First Gene Therapy for Non-Muscle-Invasive Bladder Cancerѻý> Half of patients achieved complete responses with adenoviral vector-based product Dec 16, 2022
<ѻý>'Constant Turmoil' at FDA Makes Our Food Less Safeѻý> Reflections on a new report about the agency's Human Foods Program Dec 16, 2022
<ѻý>Why Does Makena Remain on the Market?ѻý> Misguided equity claims do not resolve issues with the accelerated approval program Dec 11, 2022
<ѻý>New IDH1 Inhibitor Wins FDA Approval for Acute Myeloid Leukemiaѻý> Olutasidenib led to a 35% response rate in a study of adults with previously treated AML Dec 02, 2022
<ѻý>FDA Greenlights First Fecal Microbiota Productѻý> Rebyota approved for preventing recurrence of C. difficile infection Dec 01, 2022
<ѻý>Watch for Severe Hypocalcemia in Dialysis Patients on Prolia, FDA Warnsѻý> Agency said potential risk may require more frequent blood calcium monitoring Nov 22, 2022
<ѻý>FDA Approves First Drug to Delay Onset of Type 1 Diabetesѻý> Teplizumab will not be subject to a risk evaluation and mitigation strategy program, after all Nov 18, 2022
<ѻý>FDA Panel Endorses Kidney Disease Drug for Serum Phosphorus Controlѻý> Advisors see need for alternatives, citing suboptimal efficacy and tolerance of approved options Nov 17, 2022
<ѻý>After Rejection, Tenapanor for Kidney Disease Faces FDA's Outside Expertsѻý> Drug's effect on serum phosphorus "small and of unclear clinical significance," say FDA reviewers Nov 15, 2022
<ѻý>FDA OKs First Antibody-Drug Conjugate for Platinum-Resistant Ovarian Cancerѻý> Mirvetuximab soravtansine produced responses in almost a third of patients in pivotal trial Nov 15, 2022
<ѻý>Another Adalimumab Biosimilar Seems Set for Interchangeabilityѻý> Trial data pave way for FDA approval Nov 14, 2022
<ѻý>FDA Authorizes IL-1 Drug for Hospitalized COVID Patientsѻý> Anakinra indicated for patients with pneumonia who are at risk of severe respiratory failure Nov 09, 2022
<ѻý>COVID Spread Through Floors, Walls; Infant Pillow Warning; Paul Pelosi Dischargedѻý> Health news and commentary from around the Web gathered by ѻý staff Nov 04, 2022
<ѻý>Pulse Oximeters Need to Work Better for Dark-Skinned Patients, FDA Panel Saysѻý> Warnings to patients and providers, improved accuracy needed, advisors say Nov 02, 2022
<ѻý>The Updated COVID Boosters Could Have Been Betterѻý> From design to implementation, our bivalent shots missed the mark Oct 26, 2022
<ѻý>FDA Broadens Options for Relapsed/Refractory Multiple Myeloma With Teclistamabѻý> Bispecific antibody achieved durable responses in a majority of heavily pretreated patients Oct 25, 2022
<ѻý>Makena Is Just the Latest in Accelerated Approval Mayhemѻý> Congress must take action to reform the process Oct 24, 2022