<ѻý>Eye Drops for Presbyopia Win FDA Approvalѻý> Pilocarpine hydrochloride solution improved distance-corrected vision in two phase III trials Oct 18, 2023
<ѻý>FDA Approves First Phosphate Absorption Inhibitor for CKDѻý> Tenapanor indicated for adults on dialysis who fail on phosphate binders Oct 18, 2023
<ѻý>Pembrolizumab Wins FDA Approval in Operable Lung Cancerѻý> Checkpoint inhibitor demonstrated significant survival improvement in perioperative setting Oct 17, 2023
<ѻý>Suzanne Somers Dies; FDA Plans to Ban Hair Relaxers; Health Worker Minimum Wageѻý> Health news and commentary from around the Web gathered by ѻý staff Oct 16, 2023
<ѻý>New Oral Drug Approved for Ulcerative Colitis in Adultsѻý> S1P receptor modulator etrasimod indicated for moderately to severely active disease Oct 13, 2023
<ѻý>FDA Warns That Umbilical Cord Injection Is a Drugѻý> Company owner also has a stem cell clinic in Panama claiming to treat various conditions Oct 12, 2023
<ѻý>Combination Therapy Wins FDA Approval for BRAF-Mutated NSCLCѻý> Encorafenib plus binimetinib led to 75% ORR in untreated patients, 59% in treated patients Oct 12, 2023
<ѻý>FDA Warns on Compounded Ketamine for Psych Disordersѻý> The agency emphasized the drug is not approved for any psychiatric disorder Oct 12, 2023
<ѻý>FDA Turns Down ATTR Cardiomyopathy Drugѻý> Decision cites insufficient evidence of clinical meaningfulness Oct 09, 2023
<ѻý>Sotorasib's Confirmatory Data in NSCLC Unreliable, Says FDA Panelѻý> But agency doesn't plan to immediately push for KRAS inhibitor's withdrawal Oct 05, 2023
<ѻý>FDA Panel Endorses DFMO for Kids' High-Risk Neuroblastoma in Remissionѻý> Large improvement in event-free survival, but questions linger about sources of data Oct 04, 2023
<ѻý>Drugmaker Plans to Pull Lung Cancer Therapy From the Marketѻý> Randomized trial of mobocertinib (Exkivity) failed to confirm benefit in rare tumor type Oct 04, 2023
<ѻý>FDA Staff Highly Skeptical of Confirmatory Data on KRAS Inhibitor in NSCLCѻý> Reviewers see potentially tiny PFS benefit with sotorasib, raise concerns over "systemic bias" Oct 04, 2023
<ѻý>Novavax's Updated COVID Shot Authorized by FDAѻý> Protein-based vaccine is refreshed with 2023-2024 formula targeting XBB strain Oct 03, 2023
<ѻý>FDA Advisors to Consider DFMO Maintenance for High-Risk Neuroblastoma in Kidsѻý> Lack of options for relapsed disease versus uncertainty about supporting data Oct 03, 2023
<ѻý>A Framework to Communicate With Pregnant Patients About the RSV Vaccineѻý> A values-based decision-making framework is key Oct 03, 2023
<ѻý>FDA Greenlights Test for Cancer-Predisposing Genetic Mutationsѻý> First-of-its-kind DNA test achieved 99% accuracy for variants in dozens of genes Oct 03, 2023
<ѻý>FDA OKs Another Injectable for Rare Kidney Disorderѻý> Nedosiran approved for patients ages 9 years and older with primary hyperoxaluria type 1 Oct 02, 2023
<ѻý>Lab Tests That Escape FDA Oversight May Come Under Agency Reviewѻý> Agency proposes tighter oversight of laboratory developed tests Sep 29, 2023
<ѻý>New Option OK'd for Pompe Diseaseѻý> FDA approves two-component therapy for patients not improving on enzyme replacement therapy Sep 29, 2023
<ѻý>FDA Relents, Approves Novel Antidepressant After Many Rejectionsѻý> Gepirone extended-release approved after nearly 2 decades of trying Sep 28, 2023
<ѻý>FDA Adds Intestinal Blockage Reports to Ozempic Labelingѻý> Joins other approved GLP-1 receptor agonists in noting the potential adverse reaction Sep 28, 2023
<ѻý>FDA Panel Overwhelmingly Rejects ALS Cell Therapyѻý> Echoing concerns from agency reviewers, advisors can't find evidence of efficacy Sep 28, 2023
<ѻý>With Shutdown Likely, Policy Experts Weigh Health Risksѻý> Food safety, innovation, and community health centers all could see trickle-down effects Sep 28, 2023
<ѻý>FDA Displeased With Companies Purposely Adding Sesame to More Foodsѻý> Agency issues updated guidance for limiting cross-contamination in wake of FASTER act Sep 27, 2023
<ѻý>Mydriasis-Reversing Eye Drops Win FDA Approvalѻý> Pupil diameter normalized significantly faster with phentolamine solution in phase III trials Sep 27, 2023
<ѻý>FDA Staff Voice Serious Concerns About Investigational ALS Cell Therapyѻý> Data are "scientifically incomplete" and manufacturing info is "grossly deficient" Sep 25, 2023
<ѻý>The White House Cancer Moonshot Is a Dudѻý> We're failing to take simple steps to reduce one of the biggest causes of cancer Sep 22, 2023
<ѻý>FDA Panel: All Thumbs Down for GLP-1 Agonist Implant for Diabetesѻý> We haven't seen "the best version of this device," said panel member Sep 22, 2023
<ѻý>FDA Advisors Grapple With Logistical, Ethical Issues of Artificial Womb Technologyѻý> Further discussion about first-in-human trials is ongoing Sep 20, 2023
<ѻý>FDA Shoots Down Needle-Free EpiPen Alternative, Requests More Dataѻý> Agency asks drugmaker for a repeat-dose study before approval Sep 20, 2023
<ѻý>Third Time's a Charm for GLP-1 Diabetes Device? FDA Staff Suggest Otherwise.ѻý> Advisory committee to weigh in on safety concerns with GLP-1 receptor agonist implant Sep 20, 2023
<ѻý>Large Study Eases Fears Over Zantac-Cancer Linkѻý> In multinational cohort, cancer incidence with pulled drug no different than other H2RAs Sep 19, 2023
<ѻý>FDA Approves JAK Inhibitor That Addresses Anemia in Myelofibrosisѻý> In a phase III trial, momelotinib reduced anemia, constitutional symptoms, and splenomegaly Sep 18, 2023
<ѻý>FDA Reviewers Have Concerns About Artificial Womb Trials in Humansѻý> The Pediatric Advisory Committee will discuss if data support a safe first-in-human trial Sep 15, 2023
<ѻý>No 'Silver Bullet' for Generic Drug Shortage, House Members Toldѻý> A total of 301 drugs were in active shortage last year Sep 14, 2023
<ѻý>FDA Panel Reluctantly Backs Patisiran for ATTR Cardiomyopathyѻý> Clinical meaningfulness is a different question, however Sep 13, 2023
<ѻý>What It Will Really Take to Restore Trust in the CDCѻý> A singular narrative, consistency, and relatability are paramount Sep 13, 2023
<ѻý>FDA Warns Companies About Unapproved Ophthalmic Productsѻý> Walgreens and CVS among companies accused of marketing products with "heightened risk of harm" Sep 13, 2023
<ѻý>FDA Panel Favors Dropping OTC Decongestantѻý> Unanimous vote that the drug is ineffective Sep 12, 2023