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
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
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
Lab Tests That Escape FDA Oversight May Come Under Agency Review Agency proposes tighter oversight of laboratory developed tests 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
FDA Relents, Approves Novel Antidepressant After Many Rejections Gepirone extended-release approved after nearly 2 decades of trying 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
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
FDA Staff Voice Serious Concerns About Investigational ALS Cell Therapy Data are "scientifically incomplete" and manufacturing info is "grossly deficient" Sep 25, 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
FDA Advisors Grapple With Logistical, Ethical Issues of Artificial Womb Technology Further discussion about first-in-human trials is ongoing Sep 20, 2023
FDA Shoots Down Needle-Free EpiPen Alternative, Requests More Data Agency asks drugmaker for a repeat-dose study before approval Sep 20, 2023
Third Time's a Charm for GLP-1 Diabetes Device? FDA Staff Suggest Otherwise. Advisory committee to weigh in on safety concerns with GLP-1 receptor agonist implant Sep 20, 2023
Large Study Eases Fears Over Zantac-Cancer Link In multinational cohort, cancer incidence with pulled drug no different than other H2RAs Sep 19, 2023
FDA Approves JAK Inhibitor That Addresses Anemia in Myelofibrosis In a phase III trial, momelotinib reduced anemia, constitutional symptoms, and splenomegaly Sep 18, 2023
FDA Reviewers Have Concerns About Artificial Womb Trials in Humans The Pediatric Advisory Committee will discuss if data support a safe first-in-human trial Sep 15, 2023
No 'Silver Bullet' for Generic Drug Shortage, House Members Told A total of 301 drugs were in active shortage last year Sep 14, 2023
FDA Panel Reluctantly Backs Patisiran for ATTR Cardiomyopathy Clinical meaningfulness is a different question, however Sep 13, 2023
What It Will Really Take to Restore Trust in the CDC A singular narrative, consistency, and relatability are paramount Sep 13, 2023
FDA Warns Companies About Unapproved Ophthalmic Products Walgreens and CVS among companies accused of marketing products with "heightened risk of harm" Sep 13, 2023
Novel System Snags FDA Approval for Severe Peripheral Arterial Disease Device designed to prevent amputation in chronic limb-threatening ischemia Sep 12, 2023
Stem-Cell Mobilization Booster Wins FDA Approval for Multiple Myeloma Motixafortide plus filgrastim increased adequate harvest rate from 9.5% to 67.5% Sep 11, 2023
FDA OKs Updated COVID Shots New single-strain vaccines will exclusively target the XBB.1.5 Omicron subvariant Sep 11, 2023
How Vital Drug Shortages Happen "Fundamentally, there's something broken in how the market works" Sep 11, 2023 video
FDA Reviewers Say OTC Decongestant Doesn't Work But they acknowledge that taking the only shelf-accessible product off the market raises issues Sep 07, 2023
How to Help Patients Navigate a Newly Complex Vaccine Season The primary message should focus on the importance of the flu, RSV, and COVID vaccines Sep 05, 2023
Antiquated U.S. Laws Governing Methadone Access Must Change One-size-fits-all treatment approaches sometimes fail Aug 31, 2023
FDA Drug Approvals: Let Us See All the Evidence Clinicians and consumers are deprived of the full picture needed for informed decision-making Aug 27, 2023
