Cologuard, Exact Sciences and FDA
Summit Therapeutics Stock Jumps as Lung Cancer Drug Placed on FDA Fast Track
Key Takeaways Summit Therapeutics stock jumped Friday morning, a day after the company said its developmental lung cancer ...
Thermo Fisher's plant making infant RSV drug breached FDA rules, documents show
One of the largest contract drug manufacturing plants in the U.S. owned by Thermo Fisher Scientific over the past 10 years ...
FDA Granted Supreme Court Review in Tobacco Suit Venue Challenge
The FDA convinced the US Supreme Court to consider a case over whether an electronic cigarette manufacturer may seek review ...
The American Journal of Managed Care1h
Nivolumab Approved as Neoadjuvant, Adjuvant Therapy for NSCLC by FDA
The approval came days before the FDA’s expected deadline and makes this the only PD-1 inhibitor approved for resectable ...
FiercePharma1h
BeiGene launches PD-1 drug Tevimbra at 10% discount to Merck's Keytruda
BeiGene has officially launched its PD-1 cancer drug Tevimbra in the U.S. more than six months after receiving a much-delayed ...
ENDPOINTS NEWS21h
FDA's drug cen­ter launch­es new co­or­di­nat­ing body for mod­el­ing and sim­u­la­tion
The FDA's Center for Drug Evaluation and Research on Wednesday officially launched a new center of excellence to better ...
medtechdive19m
Elucid wins FDA 510(k) nod for heart plaque image analysis software
The software turns coronary CT angiography images into 3D models that quantify and classify plaque morphology to improve predictions of heart attack and stroke risk.
inforum17h
FDA approves the first new schizophrenia drug in over 30 years
FARGO — A new FDA approved drug, to help people with schizophrenia, will soon be accessible for medical officials to ...