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 ľֱ 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FDA Outlines Rules for Telling Clinicians About Unapproved Uses of Drugs, Devices Draft guidance explains what doesn't qualify as "scientifically sound" information Oct 31, 2023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
Soap to Fight Skin Cancer; $1,000 Early Cancer Detection Test; FDA Approval in MDS News, features, and commentary about cancer-related issues Oct 27, 2023
Novel Corticosteroid Approved for Rare Disease Vamorolone gets a nod from FDA for Duchenne muscular dystrophy Oct 27, 2023
Probiotics for Preterm Infants Could Pose Serious Danger, FDA Warns Abbott, Infinant Health sent warning letters about their products Oct 26, 2023
IG Live October 23: Life in the Fast Lane With FDA's Accelerated Approvals Experts share their perspectives on the increasingly controversial FDA pathway Oct 19, 2023
Eye Drops for Presbyopia Win FDA Approval Pilocarpine hydrochloride solution improved distance-corrected vision in two phase III trials Oct 18, 2023
FDA Approves First Phosphate Absorption Inhibitor for CKD Tenapanor indicated for adults on dialysis who fail on phosphate binders Oct 18, 2023
Pembrolizumab Wins FDA Approval in Operable Lung Cancer Checkpoint inhibitor demonstrated significant survival improvement in perioperative setting Oct 17, 2023
Suzanne Somers Dies; FDA Plans to Ban Hair Relaxers; Health Worker Minimum Wage Health news and commentary from around the Web gathered by ľֱ staff Oct 16, 2023
New Oral Drug Approved for Ulcerative Colitis in Adults S1P receptor modulator etrasimod indicated for moderately to severely active disease Oct 13, 2023
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
FDA Turns Down ATTR Cardiomyopathy Drug Decision cites insufficient evidence of clinical meaningfulness Oct 09, 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
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
