AbbVie
FDA Grants New Indication for Rinvoq—Once-Daily Pill for Crohn’s Disease
The FDA granted a new indication for Rinvoq to treat adults with moderate to severe active Crohn’s disease ...
MAY 19, 2023
Skyrizi indication Expanded for Crohn’s Disease Treatment
AbbVie announced the FDA’s approval of Skyrizi as the first specific interleukin-23 inhibitor for treatment ...
JULY 5, 2022
FDA Warns of Serious Risks, Including Death, With Tofacitinib
The FDA is requiring the addition of warnings about increased risks for cancer, serious cardiovascular events and ...
SEPTEMBER 3, 2021
FDA Grants Pediatric Indication for Mavyret for HCV
An estimated 23,000 to 46,000 children have HCV infection in the United States.
MAY 1, 2019
FDA Halts MM Trial, Deaths Seen in Venclexta Arm
The FDA halted a clinical trial of Venclexta for MM because of an increased risk for death; does not affect ...
MARCH 22, 2019
FDA Approves Orilissa for Severe Endometriosis
Orilissa is the first and only oral gonadotropin-releasing hormone antagonist specifically developed to treat women ...
JULY 26, 2018
Venclexta Approved for CLL/SLL After 1 Prior Therapy
The FDA granted regular approval to venetoclax in patients with chronic lymphocytic leukemia (CLL) or small ...
JUNE 18, 2018
FDA Approves Cyltezo, Biosimilar of Humira
Second new adalimumab biosimilar approved for multiple indications.
AUGUST 28, 2017
FDA Approves Mavyret for HCV Genotypes 1-6
Knowing which of the six distinct HCV genotypes there are can help inform treatment. Approximately 75% of Americans ...
AUGUST 7, 2017
FDA Approves Imbruvica to Treat Adults With Chronic GVHD
Imbruvica becomes the first and only therapy specifically approved for adults with cGVHD, a serious and ...
AUGUST 7, 2017
Pfizer Announces Positive Results From the Comparative Study for Potential Biosimilar to Humira
The primary end point was an equivalent ACR20 response at week 12 of study treatment.
JANUARY 6, 2017
FDA Grants Breakthrough Therapy Designation for AbbVie's Investigational HCV Regimen
Currently in Phase III clinical trials, glecaprevir/pibrentasvir is an investigational, pan-genotypic regimen being ...
SEPTEMBER 30, 2016
