<ѻýҕl>FDA Warns on Needle-Free Injection Devices for Facial Fillersѻýҕl> Serious injuries and "irreversible" harm to skin, lips, and eyes reported with unapproved devices Oct 08, 2021
<ѻýҕl>FDA Gives Thumbs Up to ANCA-Associated Vasculitis Drugѻýҕl> Approval granted to avacopan despite advisory committee concerns Oct 08, 2021
<ѻýҕl>Back-to-Back Recalls for Medtronic Insulin Pumpsѻýҕl> Class I recalls on 600 series pumps and 500 series remotes Oct 06, 2021
<ѻýҕl>FDA Clears 'Major Advancement' in CT Imagingѻýҕl> New Siemens' CT scanner is first allowed by agency with photon-counting detectors Sep 30, 2021
<ѻýҕl>The Cost of Blood Platelets Is About to Surgeѻýҕl> FDA's flawed new guidance for blood transfusion safety takes effect October 1 Sep 30, 2021
<ѻýҕl>How Many Deaths Will New Cigarette Warnings Prevent?ѻýҕl> Modeling study comes up with big numbers Sep 24, 2021
<ѻýҕl>I Got Moderna. Can I Boost With Pfizer?ѻýҕl> "There's all sorts of anarchy going on" Sep 23, 2021
<ѻýҕl>FDA Approves First Topical JAK Inhibitor for Atopic Dermatitisѻýҕl> Significant skin clearance, reduced itch in majority of patients treated with ruxolitinib cream Sep 22, 2021
<ѻýҕl>Unapproved Drug Found in Dietary Supplements Despite FDA Warningѻýҕl> Phenibut was found in all four products analyzed, with increased quantities in three Sep 22, 2021
<ѻýҕl>Pipeline Flex Endovascular Flow Diverters Under Recallѻýҕl> Serious injury and death linked to fracturing issue in the delivery system, FDA warns Sep 21, 2021
<ѻýҕl>The Technological Marvel of Combination Vaccinesѻýҕl> Many questions remain for co-formulating COVID vaccines, but pursuing this now is the right move Sep 18, 2021
<ѻýҕl>Pfizer Makes Its Case for COVID Booster Shotsѻýҕl> Ahead of advisory meeting, FDA staff notes "inferred" effectiveness, and no new safety concerns Sep 15, 2021
<ѻýҕl>Gene Therapies Require Neurologic Monitoringѻýҕl> Nerve conduction, MRI monitoring may mitigate neurotoxicity risks Sep 07, 2021
<ѻýҕl>Liver Toxicity in Gene Therapy Trials Could Merit Stricter Entry Criteriaѻýҕl> FDA panel weighs in on lower vector doses and role of animal studies Sep 03, 2021
<ѻýҕl>More Hospitals Sued Over Right to Try Ivermectinѻýҕl> More hospitals see lawsuits from family members of COVID-19 patients seeking the drug Sep 01, 2021
<ѻýҕl>Take Another Look at the Spacing Between COVID Vaccine Dosesѻýҕl> Growing body of research suggests robust immune response with extended dosing interval Sep 01, 2021
<ѻýҕl>FDA Slaps Restrictions on JAK Inhibitors Over Serious Safety Risksѻýҕl> Use for inflammatory conditions limited to those who fail on TNF blockers Sep 01, 2021
<ѻýҕl>FDA Warns on Contamination Risk With Eco-Med Ultrasound Gelsѻýҕl> Healthcare providers must toss all of company's gels and lotions, agency says Aug 19, 2021
<ѻýҕl>FDA Grants Tissue-Agnostic Approval to Dostarlimab for dMMR Tumorsѻýҕl> Overall response rate of 41.6% in various tumor types with mismatch repair deficiency Aug 18, 2021
<ѻýҕl>First Drug OK'd for Idiopathic Hypersomniaѻýҕl> Sleep drug Xywav gains a new indication Aug 12, 2021
<ѻýҕl>Notice Any Rule Changes in Washington? You Can Thank COVIDѻýҕl> "It's opened a Pandora's box, which is not going back" Aug 11, 2021
<ѻýҕl>CMS Proposes to Rescind 'Most Favored Nation' Drug Pricing Ruleѻýҕl> Regulation from Trump administration had been barred from taking effect due to court challenges Aug 09, 2021
<ѻýҕl>All Eyes on FDA: The Upcoming Regulation of Juul E-Cigarettesѻýҕl> Will the public health be protected? Aug 06, 2021
<ѻýҕl>TAVR Debris Deflector Doesn't Fly With FDA Advisory Panelѻýҕl> TriGuard 3 met with skepticism in its bid for approval Aug 04, 2021
<ѻýҕl>Monoclonal Antibody Cocktail Authorized for Post-COVID Exposureѻýҕl> REGEN-COV becomes first monoclonal antibody treatment with EUA following exposure alone Jul 30, 2021
<ѻýҕl>Call in the T-Cell Cavalry to Fight COVID in the Immunocompromisedѻýҕl> Preliminary research suggests immunotherapy could play role in protecting vaccine non-responders Jul 29, 2021
<ѻýҕl>More Medical Device Deaths Than We Previously Thought?ѻýҕl> Study finds many reports of patient deaths that were not classified as a death in FDA database Jul 27, 2021
<ѻýҕl>Shingrix OK'd for Immunocompromised Adultsѻýҕl> CDC's vaccine committee currently discussing vaccine for this population, manufacturer says Jul 26, 2021
<ѻýҕl>FDA Approves IVIG for Dermatomyositisѻýҕl> Octagam 10% lands indication for adults following results of ProDERM trial Jul 20, 2021
<ѻýҕl>FDA Warns Doctors, Consumers on Contaminated Chantixѻýҕl> Latest drug found with cancer-causing nitrosamines Jul 20, 2021
<ѻýҕl>FDA Breaks New Ground With Transplant Drug Approvalѻýҕl> No prospective trial offered or required Jul 19, 2021
<ѻýҕl>Safety Concerns Turn FDA Panel Thumbs Down for Novel CKD-Anemia Drugѻýҕl> Advisory committee rejected oral anemia drug for dialysis and non-dialysis patient populations Jul 16, 2021
<ѻýҕl>FDA Panel Nearly Unanimous on Liver Transplant Perfusion Deviceѻýҕl> Thumbs up on safety and efficacy Jul 15, 2021
<ѻýҕl>Company Shut Down Robot Mid-Surgery; Infected in Quarantine; Investigating Aduhelmѻýҕl> This past week in healthcare investigations Jul 14, 2021
<ѻýҕl>Juul Bought Out Medical Journal for $51Kѻýҕl> E-cig maker sponsored nearly a dozen studies, took over journal as it awaits FDA ruling Jul 13, 2021
<ѻýҕl>Ivermectin and Aducanumab: Do They Work?ѻýҕl> ZDoggMD and Vinay Prasad, MD, MPH, analyze the evidence Jul 13, 2021
<ѻýҕl>Walmart's Low-Price Insulin Is a Band-Aid on a Broken Systemѻýҕl> Exorbitant drug pricing and inaccessible care require government intervention Jul 11, 2021
<ѻýҕl>Finerenone OK'd for Slowing Kidney Disease in T2Dѻýҕl> Drug also indicated for cardiovascular event risk reduction Jul 09, 2021
<ѻýҕl>Alzheimer's Aducanumab Prescribing Information Changesѻýҕl> "We as neurologists need a strategy to advise our patients," experts say Jul 09, 2021
<ѻýҕl>FDA Cannot Ban Use of Electric Shock Devices for Harmful Behaviorsѻýҕl> Appeals court rules in favor of only U.S. facility still using devices for behavioral treatment Jul 09, 2021