FDA Has Neglected Clinical Trial Transparency β Plus $45 Billion in Fines It's time for more aggressive enforcement of the law Mar 21, 2023
Investigational ALS Drug May Have Clinical Benefit, FDA Staff Says Neurofilament light will be evaluated as a surrogate endpoint in tofersen review Mar 20, 2023
FDA Allows Lower Risk Designation for Snuff Product The brand joins a limited few granted modified risk tobacco claims Mar 16, 2023
CDC, FDA Heads Fire Back at Ladapo Letter Califf and Walensky say Florida Surgeon General's VAERS analysis is "incorrect, misleading" Mar 13, 2023
FDA Panel Endorses New First-Line Lymphoma Regimen POLARIX trial supports a favorable risk-benefit profile for polatuzumab vedotin, ODAC members say Mar 10, 2023
First Bimodal Neuromodulation Device for Tinnitus Gets FDA Nod Ringing ears may get relief with sound and tongue stimulation Mar 08, 2023
Only Drug to Prevent Preterm Birth Set to Leave the Market Decision follows FDA advisory committee recommendation for withdrawal Mar 08, 2023
FDA Not Quite Sold on Polivy in Frontline Large B-Cell Lymphoma Regimen Ahead of ODAC meeting, agency reviewers suggest modest PFS results in POLARIX "raise uncertainty" Mar 07, 2023
FDA Mandate on Acetaminophen-Opioid Combinations Appeared Effective Hospitalizations for liver toxicity declined after FDA limited acetaminophen dose Mar 07, 2023
First Treatment Approved for Rare Neurodegenerative Disorder Omaveloxolone gets FDA nod for Friedreich's ataxia Mar 01, 2023
Omecamtiv Mecarbil for Heart Failure Turned Down by FDA End of the road for cardiac myosin activator Mar 01, 2023
FDA Issues Import Alert on 'Tranq' Drug Xylazine Drug will be under added scrutiny to make sure it's for "legitimate veterinary use," agency says Feb 28, 2023
A Ban on the Abortion Drug Mifepristone Is Looming A Texas lawsuit may be disastrous for effective abortion access and FDA's authority Feb 23, 2023
Over-the-Counter Naloxone Has the Power to Save Lives But removing barriers to access is an essential next step Feb 23, 2023
Alzheimer's Data Faked? Docs 'Groomed' to Overuse Devices; Orphan Drug Fight This past week in healthcare investigations Feb 22, 2023
FDA Approves First Treatment for Geographic Atrophy Secondary to AMD Pegcetacoplan reduced GA lesion growth by 22% over 24 months versus sham injections Feb 18, 2023
FDA OKs First Therapy for Alpha-Mannosidosis Velmanase alfa approved for treating non-CNS manifestations of progressive, inherited disease Feb 17, 2023
Proposed User Instructions for OTC Narcan Has FDA Concerned In emergency setting, proper use and administration by consumer is "essential," says agency staff Feb 14, 2023
What Happened to the Monoclonal Antibodies for COVID-19? Losing focus on monoclonals means neglecting those who need them most: the immunocompromised Feb 13, 2023 video
FDA Warns on Use of Hospira Drug in Kids Due to 'Unsafe' Aluminum Levels Agency cites risk for aluminum toxicity in infants Feb 10, 2023
FDA Has Concerns on 'Unprecedented' Plan for Dostarlimab in Rectal Cancer Panel will discuss if single-arm trials and proposed endpoints are adequate to support approval Feb 08, 2023
How Patent Thickets Keep Cheaper Drugs Off the Market "We're transferring a huge amount of wealth from the public to drug companies," says S. Sean Tu Feb 03, 2023 video
What Doctors Should Know About Xylazine in Fentanyl Naloxone still works but additional support may be needed; wound care a challenge Feb 01, 2023
FDA Greenlights First Drug for ESR1-Mutated Breast Cancer Elacestrant almost doubled PFS versus standard endocrine therapy in advanced ER+/HER2- disease Jan 30, 2023
Doc Delivered Deadly Epidural; Hotze's Conspiracy Theory; Docs Slam Wegovy Story This past week in healthcare investigations Jan 25, 2023
FDA, NIH Must Penalize Researchers Who Don't Report Trial Results, House Member Says Many with NIH grants don't follow reporting rules, get funded again anyway, says Rep. Pallone Jan 20, 2023
CDC, FDA Flag Early Signal of Stroke Risk With Bivalent COVID Vaccine One surveillance system detects potential link in seniors, yet multiple others show none Jan 13, 2023
Legal Loophole Lets Faulty Devices Maintain Their Legacy Harlan Krumholz on how devices subject to Class I recalls are used as predicates for new devices Jan 11, 2023 video
Alzheimer's Drug Lecanemab Wins FDA Approval Anti-amyloid showed modest benefit in phase III trial, but was linked to adverse events Jan 06, 2023
Abortion Pill Can Be Dispensed in Retail Pharmacies, FDA Says Decision allows patients to pick up mifepristone at brick-and-mortar locations Jan 04, 2023
Crystal Ball Cloudy for PI3K Inhibitors' Future in Hematology After a year of negative news, some caution about throwing out the baby with the bath water Jan 02, 2023
Anti-CD20 Agent Gains Approval for Multiple Sclerosis FDA greenlights ublituximab for relapsing MS Dec 29, 2022
No, the Baby Formula Shortage Still Isn't Over Experts say regulatory changes treat symptoms but not all causes of the formula crisis Dec 28, 2022
Families Push Research Forward in Rare Diseases The field has a unique funding model. While fruitful, some question if it needs to change. Dec 26, 2022
FDA Approves First Gene Therapy for Non-Muscle-Invasive Bladder Cancer Half of patients achieved complete responses with adenoviral vector-based product Dec 16, 2022
'Constant Turmoil' at FDA Makes Our Food Less Safe Reflections on a new report about the agency's Human Foods Program Dec 16, 2022
Why Does Makena Remain on the Market? Misguided equity claims do not resolve issues with the accelerated approval program Dec 11, 2022
New IDH1 Inhibitor Wins FDA Approval for Acute Myeloid Leukemia Olutasidenib led to a 35% response rate in a study of adults with previously treated AML Dec 02, 2022
