Lymphoma Drug Copanlisib to Be Pulled From U.S. Market Failed confirmatory trial takes down another PI3K inhibitor Nov 14, 2023
Communicating Uncertainty About Drugs Granted Accelerated Approval An education gap exists about "the possibility that these drugs might not work," says expert Nov 13, 2023 video
First Treatment Approved for Genetic Clotting Disorder Adzynma indicated as prophylactic or on-demand enzyme replacement therapy in cTTP Nov 10, 2023
First Chikungunya Vaccine Lands Conditional FDA Approval High level of seroprotection, but adverse reactions warrant postmarketing study Nov 10, 2023
Competing Incentives of the FDA's Accelerated Drug Approval Experts weigh drug availability against possible suboptimal outcomes Nov 09, 2023 video
New Oral Drug Approved for Metastatic Colorectal Cancer In phase III trials of pretreated patients, fruquintinib improved survival versus placebo Nov 09, 2023
Tirzepatide Wins FDA Approval for Weight Loss Drug also gets a new brand name, Zepbound, for its new indication Nov 08, 2023
FDA Approves First Renal Denervation System for Hypertension Catheter-based technology will finally enter the market with ultrasound-based device Nov 08, 2023
FDA Panel Backs High-Risk Designation for Salvaged Blood Irradiators With Class III designation, sponsors would have to prove safety, efficacy with randomized trials Nov 07, 2023
Regulation Gap Persists in OTC Eye Care Products Poor oversight, sketchy product information endanger public health, experts say Nov 04, 2023
Evidence of Safety, Efficacy for Salvaged Blood Irradiators Lacking, FDA Staff Say Devices are aimed at preventing metastasis during surgery Nov 03, 2023
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 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FDA Outlines Rules for Telling Clinicians About Unapproved Uses of Drugs, Devices Draft guidance explains what doesn't qualify as "scientifically sound" information Oct 31, 2023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 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
