FDA Warns That Umbilical Cord Injection Is a Drug Company owner also has a stem cell clinic in Panama claiming to treat various conditions Oct 12, 2023
Combination Therapy Wins FDA Approval for BRAF-Mutated NSCLC Encorafenib plus binimetinib led to 75% ORR in untreated patients, 59% in treated patients Oct 12, 2023
FDA Warns on Compounded Ketamine for Psych Disorders The agency emphasized the drug is not approved for any psychiatric disorder Oct 12, 2023
Opposing Gun Ownership by Domestic Abusers Is My Lane Commit to speaking out during Domestic Violence Awareness Month Oct 11, 2023
FDA Turns Down ATTR Cardiomyopathy Drug Decision cites insufficient evidence of clinical meaningfulness Oct 09, 2023
Trial Design, Treatment Options Spotlighted in Xylazine Conference Clinical trials need to include more active users, researcher says Oct 06, 2023
Sotorasib's Confirmatory Data in NSCLC Unreliable, Says FDA Panel But agency doesn't plan to immediately push for KRAS inhibitor's withdrawal Oct 05, 2023
Should 'Site Neutrality' Be Used to Set Payments? MedPAC Members Disagree "I don't think 'site-neutral' is neutral," one commissioner says Oct 05, 2023
FDA Panel Endorses DFMO for Kids' High-Risk Neuroblastoma in Remission Large improvement in event-free survival, but questions linger about sources of data Oct 04, 2023
Drugmaker Plans to Pull Lung Cancer Therapy From the Market Randomized trial of mobocertinib (Exkivity) failed to confirm benefit in rare tumor type Oct 04, 2023
Coast to Coast, Kaiser Permanente Workers Start 3-Day Strike Employees picket, complain of staff shortages, burnout, low pay, and low morale Oct 04, 2023
FDA Staff Highly Skeptical of Confirmatory Data on KRAS Inhibitor in NSCLC Reviewers see potentially tiny PFS benefit with sotorasib, raise concerns over "systemic bias" Oct 04, 2023
Novavax's Updated COVID Shot Authorized by FDA Protein-based vaccine is refreshed with 2023-2024 formula targeting XBB strain Oct 03, 2023
FDA Advisors to Consider DFMO Maintenance for High-Risk Neuroblastoma in Kids Lack of options for relapsed disease versus uncertainty about supporting data Oct 03, 2023
A Framework to Communicate With Pregnant Patients About the RSV Vaccine A values-based decision-making framework is key Oct 03, 2023
FDA Greenlights Test for Cancer-Predisposing Genetic Mutations First-of-its-kind DNA test achieved 99% accuracy for variants in dozens of genes Oct 03, 2023
FDA OKs Another Injectable for Rare Kidney Disorder Nedosiran approved for patients ages 9 years and older with primary hyperoxaluria type 1 Oct 02, 2023
Clean Up the COVID Booster Mess by Returning to a Single-Payer System We must reopen the door to easy preventive care access Oct 02, 2023
AMA Too Woke? FDA Warns on Probiotics; Medicare Drug-Price Negotiation Moves Forward Health news and commentary from around the Web gathered by staff Oct 02, 2023
Lab Tests That Escape FDA Oversight May Come Under Agency Review Agency proposes tighter oversight of laboratory developed tests Sep 29, 2023
Senator Dianne Feinstein Dies at 90 Accomplishments included helping pass assault weapons ban, ACA, protecting kids from phthalates Sep 29, 2023
New Option OK'd for Pompe Disease FDA approves two-component therapy for patients not improving on enzyme replacement therapy Sep 29, 2023
Dianne Feinstein Dies; Prison for Alzheimer's Fraudsters; Kaiser Strike Looming Health news and commentary from around the Web gathered by staff Sep 29, 2023
FDA Relents, Approves Novel Antidepressant After Many Rejections Gepirone extended-release approved after nearly 2 decades of trying Sep 28, 2023
OSHA Comes in for Both Praise and Harsh Criticism at House Hearing Illinois lawmaker calls agency head "inept" during discussion of COVID vaccine mandate rule Sep 28, 2023
FDA Adds Intestinal Blockage Reports to Ozempic Labeling Joins other approved GLP-1 receptor agonists in noting the potential adverse reaction Sep 28, 2023
Obamacare Makes Surprise Cameo in Second GOP Debate Fentanyl crisis, transgender care, and abortion also got some air time Sep 28, 2023
FDA Panel Overwhelmingly Rejects ALS Cell Therapy Echoing concerns from agency reviewers, advisors can't find evidence of efficacy Sep 28, 2023
With Shutdown Likely, Policy Experts Weigh Health Risks Food safety, innovation, and community health centers all could see trickle-down effects Sep 28, 2023
FDA Displeased With Companies Purposely Adding Sesame to More Foods Agency issues updated guidance for limiting cross-contamination in wake of FASTER act Sep 27, 2023
Mydriasis-Reversing Eye Drops Win FDA Approval Pupil diameter normalized significantly faster with phentolamine solution in phase III trials Sep 27, 2023
States Face Challenges With Medicaid and CHIP 'Redeterminations' CMS officials flag problem with states' auto-renewal systems Sep 27, 2023
Preventing Biden's Stumbles; Bruce Willis Aware of His Dementia? ABIM Prez to Retire Health news and commentary from around the Web gathered by staff Sep 27, 2023
FTC Sues Anesthesia Group and Its Private Equity Backers Companies accused of extracting "monopoly profits" while growing "monopoly power" Sep 26, 2023
COVID Drug and New Mutations; Costco Offers $29 Care; Trump Unmasked Over Bronzer Health news and commentary from around the Web gathered by staff Sep 26, 2023
FDA Staff Voice Serious Concerns About Investigational ALS Cell Therapy Data are "scientifically incomplete" and manufacturing info is "grossly deficient" Sep 25, 2023
Two Large Medical Groups Shun Medicare Advantage Plans San Diego doctor groups latest to withdraw, citing low pay, prior authorization problems Sep 25, 2023
White House Opens Gun Violence Prevention Office "We have to act, and we have to act now," says President Biden Sep 22, 2023
The White House Cancer Moonshot Is a Dud We're failing to take simple steps to reduce one of the biggest causes of cancer Sep 22, 2023
FDA Panel: All Thumbs Down for GLP-1 Agonist Implant for Diabetes We haven't seen "the best version of this device," said panel member Sep 22, 2023
