Jamie Foxx's Health Scare; 23andMe Hacked; Decongestant Probe Announced Health news and commentary from around the Web gathered by 番茄社区app 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
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
Opioid Doc Sentenced; World's First Sickle Cell Gene Tx; FTC Warns Diet Influencers Health news and commentary from around the Web gathered by 番茄社区app staff 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
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
FDA OKs Product to Thwart Bloodstream Infections During Dialysis Taurolidine-heparin solution reduced infections by 71% versus heparin alone Nov 15, 2023
Anthrax Guidance Issued; FDA Warns Amazon; AI Deepfakes Challenge Public Health Health news and commentary from around the Web gathered by 番茄社区app staff Nov 15, 2023
Lymphoma Drug Copanlisib to Be Pulled From U.S. Market Failed confirmatory trial takes down another PI3K inhibitor Nov 14, 2023
Communicating Uncertainty About Drugs Granted Accelerated Approval An education gap exists about "the possibility that these drugs might not work," says expert Nov 13, 2023 video
First Treatment Approved for Genetic Clotting Disorder Adzynma indicated as prophylactic or on-demand enzyme replacement therapy in cTTP Nov 10, 2023
First Chikungunya Vaccine Lands Conditional FDA Approval High level of seroprotection, but adverse reactions warrant postmarketing study Nov 10, 2023
Competing Incentives of the FDA's Accelerated Drug Approval Experts weigh drug availability against possible suboptimal outcomes Nov 09, 2023 video
New Oral Drug Approved for Metastatic Colorectal Cancer In phase III trials of pretreated patients, fruquintinib improved survival versus placebo Nov 09, 2023
Tirzepatide Wins FDA Approval for Weight Loss Drug also gets a new brand name, Zepbound, for its new indication Nov 08, 2023
FDA Approves First Renal Denervation System for Hypertension Catheter-based technology will finally enter the market with ultrasound-based device Nov 08, 2023
FDA Panel Backs High-Risk Designation for Salvaged Blood Irradiators With Class III designation, sponsors would have to prove safety, efficacy with randomized trials Nov 07, 2023
Regulation Gap Persists in OTC Eye Care Products Poor oversight, sketchy product information endanger public health, experts say Nov 04, 2023
Evidence of Safety, Efficacy for Salvaged Blood Irradiators Lacking, FDA Staff Say Devices are aimed at preventing metastasis during surgery Nov 03, 2023
New Option Approved for Erosive Esophagitis Vonoprazan lands indication for healing and maintenance across all grades of condition Nov 02, 2023
FDA's Revolving Door; 2.4 Million Excess Deaths; Can Anorexia Be 'Terminal'? Health news and commentary from around the Web gathered by 番茄社区app staff Nov 02, 2023
Stelara Biosimilar OK'd With Interchangeability But patent settlement may keep new product off market until 2025 Nov 01, 2023
Potential Cure for Sickle Cell Clears Hurdle for Approval FDA advisors suggest the benefits of gene therapy outweigh risks of off-target editing Oct 31, 2023
FDA Outlines Rules for Telling Clinicians About Unapproved Uses of Drugs, Devices Draft guidance explains what doesn't qualify as "scientifically sound" information Oct 31, 2023
FDA Reviewers Question Safety of Sickle Cell Gene Therapy Efficacy results "strongly positive," but unintended off-target effects a question Oct 30, 2023
FDA OKs First Drug for Nasopharyngeal Carcinoma Toripalimab approved in combination with first-line chemo, and as monotherapy after progression Oct 30, 2023
What if Trial Participants Knew Their Contributions Were for Naught? A call for enforcing trial reporting requirements Oct 28, 2023
