Janssen’s Invokana became the only medicine in nearly 20 years and the first diabetes medicine ever to demonstrate a reduction in progression to end-stage renal failure in T2D patients with CKD.
The Food and Drug Administration approved Insmed Inc.’s lead drug Arikayce to treat a rare chronic lung disease.
The U.S. FDA approved AstraZeneca Plc’s treatment for hairy cell leukemia, a slow-growing type of blood cancer.
The FDA approved Biktarvy, Gilead’s once-daily, triple-combo tablet for treating HIV infection, paving the way for the biotech company to capture more of the multibillion-dollar HIV drug market.
The U.S. FDA approved two doses of Pfizer Inc.’s medicine Xeljanz for treating active psoriatic arthritis.
Indivior PLC announced that the U.S. FDA approved Sublocade (buprenorphine extended-release) injection for subcutaneous use (CIII), the first and only once-monthly injectable buprenorphine formulation for the treatment of moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a transmucosal buprenorphine-containing product followed by dose adjustment for a minimum of seven days.
The U.S. Food and Drug Administration approved Roche’s first-in-class therapy Hemlibra for hemophilia suffers.
The U.S. Food and Drug Administration approved Pfizer Inc.’s rare blood cancer drug Besponsa with a boxed warning.
The FDA approved updated labeling for Gilead Sciences’ chronic hepatitis C virus drug Epclusa to include use in patients co-infected with HIV.
The U.S. FDA approved Celgene Corp. and Agios Pharmaceuticals Inc.’s oral treatment for acute myeloid leukemia patients with a specific genetic mutation.