<ѻýҕl>FDA Outlines Rules for Telling Clinicians About Unapproved Uses of Drugs, Devicesѻýҕl> Draft guidance explains what doesn't qualify as "scientifically sound" information Oct 31, 2023
<ѻýҕl>FDA Reviewers Question Safety of Sickle Cell Gene Therapyѻýҕl> Efficacy results "strongly positive," but unintended off-target effects a question Oct 30, 2023
<ѻýҕl>FDA OKs First Drug for Nasopharyngeal Carcinomaѻýҕl> Toripalimab approved in combination with first-line chemo, and as monotherapy after progression Oct 30, 2023
<ѻýҕl>What If Trial Participants Knew Their Contributions Were for Naught?ѻýҕl> A call for enforcing trial reporting requirements Oct 28, 2023
<ѻýҕl>Novel Drug OK'd for Ulcerative Colitisѻýҕl> First agent to target p19 subunit of IL-23 Oct 27, 2023
<ѻýҕl>Soap to Fight Skin Cancer; $1,000 Early Cancer Detection Test; FDA Approval in MDSѻýҕl> News, features, and commentary about cancer-related issues Oct 27, 2023
<ѻýҕl>Novel Corticosteroid Approved for Rare Diseaseѻýҕl> Vamorolone gets a nod from FDA for Duchenne muscular dystrophy Oct 27, 2023
<ѻýҕl>Probiotics for Preterm Infants Could Pose Serious Danger, FDA Warnsѻýҕl> Abbott, Infinant Health sent warning letters about their products Oct 26, 2023
<ѻýҕl>AAP Warns on So-Called Toddler Formulasѻýҕl> Beverages are "not nutritionally complete" and not meant for kids with major illness, report says Oct 21, 2023
<ѻýҕl>IG Live October 23: Life in the Fast Lane With FDA's Accelerated Approvalsѻýҕl> Experts share their perspectives on the increasingly controversial FDA pathway Oct 19, 2023
<ѻýҕl>Eye Drops for Presbyopia Win FDA Approvalѻýҕl> Pilocarpine hydrochloride solution improved distance-corrected vision in two phase III trials Oct 18, 2023
<ѻýҕl>FDA Approves First Phosphate Absorption Inhibitor for CKDѻýҕl> Tenapanor indicated for adults on dialysis who fail on phosphate binders Oct 18, 2023
<ѻýҕl>Pembrolizumab Wins FDA Approval in Operable Lung Cancerѻýҕl> Checkpoint inhibitor demonstrated significant survival improvement in perioperative setting Oct 17, 2023
<ѻýҕl>Suzanne Somers Dies; FDA Plans to Ban Hair Relaxers; Health Worker Minimum Wageѻýҕl> Health news and commentary from around the Web gathered by ѻýҕl staff Oct 16, 2023
<ѻýҕl>New Oral Drug Approved for Ulcerative Colitis in Adultsѻýҕl> S1P receptor modulator etrasimod indicated for moderately to severely active disease Oct 13, 2023
<ѻýҕl>FDA Warns That Umbilical Cord Injection Is a Drugѻýҕl> Company owner also has a stem cell clinic in Panama claiming to treat various conditions Oct 12, 2023
<ѻýҕl>Combination Therapy Wins FDA Approval for BRAF-Mutated NSCLCѻýҕl> Encorafenib plus binimetinib led to 75% ORR in untreated patients, 59% in treated patients Oct 12, 2023
<ѻýҕl>FDA Warns on Compounded Ketamine for Psych Disordersѻýҕl> The agency emphasized the drug is not approved for any psychiatric disorder Oct 12, 2023
<ѻýҕl>FDA Turns Down ATTR Cardiomyopathy Drugѻýҕl> Decision cites insufficient evidence of clinical meaningfulness Oct 09, 2023
<ѻýҕl>Sotorasib's Confirmatory Data in NSCLC Unreliable, Says FDA Panelѻýҕl> But agency doesn't plan to immediately push for KRAS inhibitor's withdrawal Oct 05, 2023
<ѻýҕl>FDA Panel Endorses DFMO for Kids' High-Risk Neuroblastoma in Remissionѻýҕl> Large improvement in event-free survival, but questions linger about sources of data Oct 04, 2023
<ѻýҕl>Drugmaker Plans to Pull Lung Cancer Therapy From the Marketѻýҕl> Randomized trial of mobocertinib (Exkivity) failed to confirm benefit in rare tumor type Oct 04, 2023
<ѻýҕl>FDA Staff Highly Skeptical of Confirmatory Data on KRAS Inhibitor in NSCLCѻýҕl> Reviewers see potentially tiny PFS benefit with sotorasib, raise concerns over "systemic bias" Oct 04, 2023
<ѻýҕl>Novavax's Updated COVID Shot Authorized by FDAѻýҕl> Protein-based vaccine is refreshed with 2023-2024 formula targeting XBB strain Oct 03, 2023
<ѻýҕl>FDA Advisors to Consider DFMO Maintenance for High-Risk Neuroblastoma in Kidsѻýҕl> Lack of options for relapsed disease versus uncertainty about supporting data Oct 03, 2023
<ѻýҕl>A Framework to Communicate With Pregnant Patients About the RSV Vaccineѻýҕl> A values-based decision-making framework is key Oct 03, 2023
<ѻýҕl>FDA Greenlights Test for Cancer-Predisposing Genetic Mutationsѻýҕl> First-of-its-kind DNA test achieved 99% accuracy for variants in dozens of genes Oct 03, 2023
<ѻýҕl>FDA OKs Another Injectable for Rare Kidney Disorderѻýҕl> Nedosiran approved for patients ages 9 years and older with primary hyperoxaluria type 1 Oct 02, 2023
<ѻýҕl>Lab Tests That Escape FDA Oversight May Come Under Agency Reviewѻýҕl> Agency proposes tighter oversight of laboratory developed tests Sep 29, 2023
<ѻýҕl>New Option OK'd for Pompe Diseaseѻýҕl> FDA approves two-component therapy for patients not improving on enzyme replacement therapy Sep 29, 2023
<ѻýҕl>FDA Relents, Approves Novel Antidepressant After Many Rejectionsѻýҕl> Gepirone extended-release approved after nearly 2 decades of trying Sep 28, 2023
<ѻýҕl>FDA Adds Intestinal Blockage Reports to Ozempic Labelingѻýҕl> Joins other approved GLP-1 receptor agonists in noting the potential adverse reaction Sep 28, 2023
<ѻýҕl>FDA Panel Overwhelmingly Rejects ALS Cell Therapyѻýҕl> Echoing concerns from agency reviewers, advisors can't find evidence of efficacy Sep 28, 2023
<ѻýҕl>With Shutdown Likely, Policy Experts Weigh Health Risksѻýҕl> Food safety, innovation, and community health centers all could see trickle-down effects Sep 28, 2023
<ѻýҕl>FDA Displeased With Companies Purposely Adding Sesame to More Foodsѻýҕl> Agency issues updated guidance for limiting cross-contamination in wake of FASTER act Sep 27, 2023
<ѻýҕl>Mydriasis-Reversing Eye Drops Win FDA Approvalѻýҕl> Pupil diameter normalized significantly faster with phentolamine solution in phase III trials Sep 27, 2023
<ѻýҕl>FDA Staff Voice Serious Concerns About Investigational ALS Cell Therapyѻýҕl> Data are "scientifically incomplete" and manufacturing info is "grossly deficient" Sep 25, 2023
<ѻýҕl>The White House Cancer Moonshot Is a Dudѻýҕl> We're failing to take simple steps to reduce one of the biggest causes of cancer Sep 22, 2023
<ѻýҕl>FDA Panel: All Thumbs Down for GLP-1 Agonist Implant for Diabetesѻýҕl> We haven't seen "the best version of this device," said panel member Sep 22, 2023
<ѻýҕl>FDA Advisors Grapple With Logistical, Ethical Issues of Artificial Womb Technologyѻýҕl> Further discussion about first-in-human trials is ongoing Sep 20, 2023