What Exactly Is a 'Critical' Medical Device? FDA Seeks Advice on the Issue Advisory panel to consider which devices should be on a list for shortage notifications Feb 05, 2024
As Investors Pile Into Psychedelics, Idealism Gives Way to Pharma Economics Challenges abound for the burgeoning sector Feb 05, 2024
Ketamine Therapy for Mental Health a ‘Wild West’ for Doctors and Patients For some patients it's a "light at the end of the tunnel" Feb 04, 2024
FDA Advisory Panel Generally Pleased With Pulse Oximetry Clinical Trial Proposal But some questions arose regarding number of participants, permissible variance in measurements Feb 03, 2024
First Transcatheter Tricuspid Regurgitation Treatment Approved FDA greenlights system for severe cases cleared by the heart team Feb 02, 2024
U.S. Officials Call for More Programs, Education to Improve Diets in America More research on "gut-brain axis" is also needed Feb 02, 2024
Pulse Oximeters Once Again in the Spotlight at FDA Advisory panel to discuss how to improve device accuracy for patients with darker skin Jan 31, 2024
Controversial Alzheimer's Drug Abandoned Biogen will stop developing and selling aducanumab Jan 31, 2024
FDA OKs Farapulse Pulsed Field Ablation System for Intermittent Afib Second catheter-based system approved for paroxysmal Afib Jan 31, 2024
Miracle Cures: Conspiracy Theories Are Fueling a New Age of Unproven Treatments Social media and online skepticism feed fears about traditional care Jan 31, 2024
Penis-Pump Company Chided by FDA The agency is not enthused by the company's clitoral claims either Jan 29, 2024
Kate Middleton Discharged; Philips to Halt Apnea Device Sales; Pet Dragon Warning Health news and commentary from around the Web gathered by 鶹ý staff Jan 29, 2024
How Much Do Physicians Really Know About FDA Drug and Device Regulation? More education is clearly needed Jan 28, 2024
When a Revolutionary Cancer Treatment Causes Cancer The potential benefits of CAR T-cell therapies still far outweigh the risks Jan 27, 2024
CAR-T Investigation: FDA Leaders Detail Decision on Cancer Risk Warning Post-treatment cases grow to 22 since products' initial approvals Jan 24, 2024
FDA Calls for New Boxed Warning on All CAR-T Products Most serious warning would alert patients, providers on potential risk for secondary malignancies Jan 23, 2024
New FDA Boxed Warning; College Shaken by Suicides; More Get Flu Shot Than COVID Vax Health news and commentary from around the Web gathered by 鶹ý staff Jan 23, 2024
FDA Warns Exosome Maker for Marketing Outside Its IND Agency also raises concern about a potentially contaminated product batch Jan 22, 2024
The Healthcare Landscape Is Changing. Our Regulatory Practices Should Too. Closer collaboration between FDA and CMS is the need of the hour Jan 22, 2024
Physicians Don't Always Understand the FDA Approval Process, Survey Finds Most preferred two or more randomized trials as evidence required for approval Jan 19, 2024
Anti-Tobacco Activists Hold 'Menthol Funeral' in Washington Speakers urge Biden to release long-delayed final rule banning menthol-flavored tobacco products Jan 18, 2024
King Charles III's Surgery; COVID Timeline Doubted; FDA Approvals Hit High Health news and commentary from around the Web gathered by 鶹ý staff Jan 18, 2024
FDA Clears AI-Powered Non-Invasive Skin Cancer Detector Intended for use in primary care, handheld device is first of its kind Jan 17, 2024
Novel Antiviral Shortens COVID Illness in Outpatients, Reduces Viral Load But trial did not provide data on the most clinically relevant outcomes, says expert Jan 17, 2024
Company Warned Over Human Placenta Product FDA tells MiMedx that its wound-healing product must be regulated as a biologic drug Jan 17, 2024
FDA Expands Pembrolizumab Approval in Cervical Cancer PD-1 inhibitor approved in combination with CRT for locally advanced disease Jan 16, 2024
The Sackler Family Can Act Today to Compensate Opioid Overdose Victims But it appears unlikely they will take this course of action Jan 14, 2024
Medicare Doc Payment Fix Bill Moving Along, GOP Doctors Caucus Co-Chair Says Rep. Greg Murphy, MD, is hoping for action within a week Jan 12, 2024
FDA Clears Wegovy, Other GLP-1 Drugs of Suicidality Risk for Now Preliminary evaluation reassures, while the agency's review continues Jan 11, 2024
Was the Name 'Operation Warp Speed' Misleading? Paul Offit reflects on how FDA communication may have led to vaccine hesitancy Jan 09, 2024 video
At-Home Treatment for Molluscum Contagiosum Wins FDA Approval Berdazimer gel led to 30% complete/near-complete clearance after 12 weeks in randomized trials Jan 08, 2024
FDA Approves Florida's Proposal to Import Prescription Drugs From Canada Drugmakers say they're "considering all options" in response Jan 05, 2024
Paul Offit Debunks Florida Surgeon General's Anti-Vax Warning "It is hard to believe that Dr. Ladapo actually issued that statement," said vaccine expert Jan 05, 2024 video
U.S. Rep's Death Medical Negligence? FDA Investigates GLPs; Fingerprint Mammograms Health news and commentary from around the Web gathered by 鶹ý staff Jan 05, 2024
FDA Warns of Toxic Oleander in Supplements Dangerous substitution once again found in tejocote root products Jan 04, 2024
FDA Warns Amazon Over Supplements Containing Erectile Dysfunction Drugs Agency bought and tested products that were found to contain tadalafil and sildenafil Dec 29, 2023
Bernie Sanders Has COVID; Global Fake Ozempic Problem; Nitazenes, the New Fentanyl? Health news and commentary from around the Web gathered by 鶹ý staff Dec 29, 2023
Ketamine and Chronic Pain; Ivermectin Lawsuit and Public Health; JN.1 Keeps Growing Health news and commentary from around the Web gathered by 鶹ý staff Dec 27, 2023
Deep Flaws in FDA's Device Oversight, and Patient Harm, Exposed in Lawsuits, Records "What is the threshold for the FDA to step in and do something?" Dec 24, 2023
FDA Approves New Agent for Nerve Pain From Rare Inherited Disease Eplontersen gets a nod for polyneuropathy from hereditary transthyretin-mediated amyloidosis Dec 22, 2023
