New York Attorney General Letitia James wants FDA to take action against asthma, allergy drug Singulair
There are concerns about an asthma and allergy drug that New York Attorney General Letitia James says could have harmful effects on children who use it.

As FDA Filing Approaches for Tab-Cel in EBV+ PTLD, Decades of Science Bear Fruit
Cancer can emerge from many corners. For some patients, it can start with a cure.

Sanofi, Regeneron get a step closer on Dupixent COPD nod with FDA priority review
An approval would make it available as an add-on maintenance treatment for adults with uncontrolled COPD with type 2 inflammation, making in the process Dupixent the first biologic therapy for COPD and the first new treatment approach for the disease in more than a decade

Cancer Test Focused Guardant Health Stock Falls On FDA AdCom Update For Colorectal Test
Precision oncology revenue grew 25% to $142.2 million, driven predominantly by an increase in clinical and biopharma testing volume

Oncopeptides' Pepaxto reaches end of the line in US after FDA yanks approval
Pepaxto was approved in the U.S. in February 2021 under the FDA’s accelerated pathway. Oncopeptides subsequently removed the drug from the market eight months later after a confirmatory trial put Pepaxto’s risk-benefit profile into question.

BrainStorm submits SPA request to FDA for Phase 3 study design
BrainStorm Cell Therapeutics (NASDAQ:BCLI) said it has submitted a Special Protocol Assessment request to the FDA for a Phase 3b study of its cell therapy NurOwn in the treatment of ALS.

Mass Tort Implications of FDA’s First of its Kind State Drug Importation Program
The program could subject foreign drug manufacturers to U.S. courts, and companies considering participating in SIP should think ahead about their defense strategies should they face litigation such as for product liability and mass torts.

Cell engineering team links cancer drug to potential therapy for Alzheimer's disease
In experiments with lab-grown brain cells and mouse models, scientists at Johns Hopkins Medicine say they have discovered that a cell surface protein called Lag3 is not only a biological target for FDA-approved drugs that stimulate the immune system to attack cancer, but also may be a target for a drug designed to clean up "misfolded" Tau proteins linked to Alzheimer's disease.

Cyberattack leaves patients facing the choice to pay – or wait for their prescriptions
As a cyberattack continues to disrupt insurance processing at pharmacies across the United States, people like Mara Furlich are facing a stark choice: Pay, at least initially, out of pocket for critical care or risk the health consequences of not getting treatment.

New implantable device helping heart patients
It improves your quality of life and your functional capacity, reduce your risk for hospitalization, but it also improves the likelihood that you would not require a heart transplant or a ventricular assist device