New First-Line Option for Pancreatic Cancer Approved Liposomal irinotecan-based regimen gets FDA greenlight for metastatic disease Feb 13, 2024
FDA Reviewers Skeptical on TriClip for Tricuspid Regurgitation Tricuspid valve repair system is up for advisory committee scrutiny on Tuesday Feb 12, 2024
Sleep Apnea Smartwatch Feature Gets FDA Authorization Software is first of its kind to receive agency greenlight, set to roll out this year Feb 12, 2024
FDA Approves First Oral Option for Eosinophilic Esophagitis Fixed-duration course of corticosteroid indicated for patients 11 years and up Feb 12, 2024
Phenylephrine Sales Steady Before FDA Panel Called It Ineffective But reformulation of products containing OTC "decongestant" could affect the supply chain Feb 09, 2024
Publisher Retracts Three Abortion Studies Two of the studies were cited by a federal judge in the case against the abortion pill Feb 08, 2024
Resmetirom Poised to Become First NASH Treatment Phase III study demonstrated drug is effective in resolving NASH and improving liver fibrosis Feb 07, 2024
FDA Panel Mulls Which Devices Are Critical in a Public Health Emergency "If we have a thermonuclear war, all I need is a scalpel," one panel member said Feb 06, 2024
Patients and Doctors Push Back Against the Harsh Side Effects of Cancer Drugs "If the patients are not taking the drug, then it's not going to work" Feb 06, 2024
Medicine or Candy? Let's Reevaluate the Vitamins We Offer to Kids Children should give standard pills a try before turning to alternatives Feb 06, 2024
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 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 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 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
