The U.S. Food and Drug Administration approved Genentech’s Tecentriq plus chemotherapy as a first-line treatment of metastatic non-squamous non-small cell lung cancer.
The U.S. Food and Drug Administration approved an expanded indication for Sanofi’s Toujeo (insulin glargine injection) for blood sugar control in adult and pediatric patients who are ages 6 years and older. The expanded indication approved by the FDA applies to both type 1 and 2 diabetes. Previously, Toujeo was U.S.-approved only for adults aged 18 years and older.
Allergan’s Botox was given the green light from the U.S. FDA to treat pediatric patients with lower limb spasticity.
The U.S. Food and Drug Administration approved Janssen’s Stelara (ustekinumab) for the treatment of adult patients with moderately to severely active ulcerative colitis.
AstraZeneca’s blockbuster drug Farxiga won U.S. approval as a treatment to reduce the chances of hospitalization for heart failure in adults with type 2 diabetes and other cardiovascular risks.
The U.S. Food and Drug Administration approved Alexion Pharmaceuticals Inc.’s Ultomiris for the treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy for adult and pediatric patients.
Genentech’s flu medication Xofluza won a new indication for the treatment of acute, uncomplicated influenza in people 12 years of age and older who have been symptomatic for less than 48 hours and are at high risk of flu-related complications.
The U.S. FDA approved Janssen’s Xarelto (rivaroxaban) for preventing blood clots in acutely sick patients in hospitals who are at risk for blood clots but who are not at high risk of bleeding.
Janssen’s Invokana Becomes First Drug Approved in 20 Years to Slow Diabetic Kidney Disease
Approvals, Cardiovascular Deaths, Clinical Studies, Diabetic Kidney Disease, End-Stage Kidney Disease, FDA, FDA/Regulatory, Heart Failure, Kidney Disease Progression, Kidney Functioning, New Indications, SGLT2 Inhibitors, Type 2 DiabetesInvokana won U.S. approval to reduce the risk of end-stage kidney disease, cardiovascular death and worsening of kidney function in adults with type 2 diabetes and diabetic kidney disease.
The U.S. Food and Drug Administration gave the green light to Johnson & Johnson’s Janssen for Erleada (apalutamide) as a treatment for metastatic castration-sensitive prostate cancer.
