Ketamine and Chronic Pain; Ivermectin Lawsuit and Public Health; JN.1 Keeps Growing Health news and commentary from around the Web gathered by ΒιΆΉ΄«Γ½ 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
FDA Warns of Unapproved Fat-Dissolving Injections Users have experienced permanent scars, infections Dec 21, 2023
FDA Rejects Drug for Chronic Cough Agency cites efficacy concerns in review of P2X3 receptor antagonist gefapixant Dec 21, 2023
First Test to Identify Opioid Addiction Risk Approved by FDA Genetic test intended to be used before patients are exposed to oral opioids for acute pain Dec 20, 2023
Bronchoscopes Recalled Over Burns, Fires in Patients' Airways Reports involved Olympus scopes used during high-frequency cauterization while supplying oxygen Dec 20, 2023
Topical Treatment for Epidermolysis Bullosa Wins FDA Approval Significantly more wounds healed within 45 days with birch triterpenes gel than with control gel Dec 19, 2023
FDA Approves New First-Line Standard of Care in Bladder Cancer Enfortumab vedotin plus pembrolizumab doubled survival as compared with chemotherapy Dec 15, 2023
FDA Approves Belzutifan for Advanced Renal Cell Carcinoma HIF-2 inhibitor indicated for patients who progress after immunotherapy and anti-VEGF Dec 15, 2023
Implant for Ocular Hypertension, Glaucoma Gets FDA Green Light A single travoprost implant proved noninferior to timolol eye drops, with good safety Dec 14, 2023
First Pulsed Field Ablation Catheter Approved for Afib Device is the first of a new class of non-thermal ablation catheters to get FDA's blessing Dec 14, 2023
Experts, Lawmakers Explore Downside of Drug-Price Negotiation Stifled innovation, reduced access suggested as future challenges Dec 14, 2023
FDA OKs Maintenance Option for High-Risk Neuroblastoma Eflornithine approved to reduce relapse risk in both kids and adults Dec 14, 2023
The FDA's Inequitable Conduct Problem Study finds that about half of all inequitable conduct cases were for FDA-regulated products Dec 12, 2023 video
A Closer Look at the Approval of CRISPR/Cas9 Gene Therapy for Sickle Cell Disease This landmark event brings up broader considerations and implications for other diseases Dec 11, 2023
FDA Inspections of Foreign Drug Manufacturers Haven't Bounced Back After Pandemic Overseas inspections "well below" pre-pandemic surveillance Dec 08, 2023
Milestone Gene Therapies for Sickle Cell Disease Greenlit by FDA Casgevy and Lyfgenia approved for one-time treatment of sickle cell disease Dec 08, 2023
FDA Clears First At-Home Kit for Artificial Insemination Intravaginal device was deemed "substantially equivalent" to clinically used intrauterine device Dec 07, 2023
FDA Approves Oral Factor B Inhibitor for Paroxysmal Nocturnal Hemoglobinuria Iptacopan tops C5 Inhibitors for sustained hemoglobin levels, eliminating need for transfusion Dec 06, 2023
Jamie Foxx's Health Scare; 23andMe Hacked; Decongestant Probe Announced Health news and commentary from around the Web gathered by ΒιΆΉ΄«Γ½ staff Dec 05, 2023
Don't Neglect Tobacco Use in People Experiencing Homelessness Cessation programs can save lives and improve financial stability Dec 04, 2023
Gaming the Patent System Can Keep Biosimilars Off the Market for Decades Sean Tu, PhD, JD, explains trade secret laws and patent laws for biologics Dec 04, 2023 video
Non-Covalent BTK Inhibitor Approved for CLL Response rates with pirtobrutinib reached 72% in heavily pretreated patient population Dec 04, 2023
FDA Clears First Oral Device Treatment for Severe Sleep Apnea Oral appliances represent an alternative to CPAP and surgical neurostimulation implants Nov 30, 2023
FDA Warns That Philips' CPAP Machines May Overheat Thermal issues including burns, smoke, fire among reports submitted by DreamStation 2 users Nov 29, 2023
FDA Warns of Rare Life-Threatening Reaction to Anti-Seizure Drugs Prescribing information changed for levetiracetam, clobazam Nov 28, 2023
FDA Investigating 'Serious Risk' of Malignancy After CAR-T Therapy Applies to all approved therapies, but benefits still outweigh risks, agency says Nov 28, 2023
FDA Approves First Therapy for Progressive Desmoid Tumors Nirogacestat reduced the risk of disease progression or death by 71% in randomized trial Nov 28, 2023
Biden Administration Announces Actions to Strengthen the Drug Supply Chain Biden will use the Defense Production Act to increase American production of some medications Nov 27, 2023
Devastating Medication Error; FDA's Recall Weakness; Insurers Break State Laws This past week in healthcare investigations Nov 22, 2023
What to Know About Ongoing Eye Drop Recalls FDA was spurred into action by a deadly bacterial outbreak earlier this year, advocates say Nov 20, 2023
Drug Candidate for Chronic Cough Rejected by FDA Panel Gefapixant's benefit not clinically meaningful enough, panelists say Nov 17, 2023
First AKT Inhibitor Approved for Advanced Breast Cancer Capivasertib plus fulvestrant doubled progression-free survival versus fulvestrant-placebo Nov 17, 2023
FDA Panel: Tolerating Approval Outliers Would Set 'Dangerous Precedent' No easy answers for two drugs for rare lymphoma on long cruise with accelerated approval Nov 16, 2023
What to Know About Lead Toxicity and Kids' Applesauce Hospitalization for acute lead toxicity can start at 45 mcg/dL Nov 16, 2023
First At-Home Test for Chlamydia and Gonorrhea Authorized by FDA OTC option arrives amid rising cases of the sexually transmitted infections Nov 16, 2023
FDA OKs New Option for Advanced ROS1-Positive Lung Cancer Drug achieved high response rates in TKI-naive and TKI-pretreated patients Nov 16, 2023
Unclear if Chronic Cough Drug Has Meaningful Benefit, FDA Reviewers Say Previously rejected gefapixant will face agency's panel of outside experts on Friday Nov 16, 2023
