USFDA

- Read more about U.S. FDA Approves Pfizer’s XELJANZ® (tofacitinib) for the Treatment of Active Polyarticular Course Juvenile Idiopathic Arthritis
Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved XELJANZ® (tofacitinib) for the treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA). Two formulations were approved, a tablet and an oral solution, and are dosed based upon weight. This approval makes XELJANZ the first and only Janus kinase (JAK) inhibitor approved in the U.S. for the treatment of pcJIA.
- Read more about Strides receives USFDA approval for Butalbital, Acetaminophen, and Caffeine Tablets
Strides Pharma Science Limited (Strides) today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325 mg/40 mg from the United States Food & Drug Administration (USFDA).
- Read more about Zydus Cadila receives approval from USFDA for Doxorubicin Hydrochloride Liposome Injection
- Read more about Alembic Pharmaceuticals receives USFDA Tentative Approval for Treprostinil Injection
- Read more about Zydus Cadila receives final approval from the USFDA for Cisatracurium Besylate Injection
Zydus Cadila has received final approval from the USFDA to market Cisatracurium Besylate Injection USP (US RLD: Nimbex ®) in the strength of 20 mg (base)/10 mL (2 mg/mL) Multiple-Dose Vial.
- Read more about Granules Pharmaceuticals, Inc received USFDA approval for Ramelteon Tablets, 8 mg
US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI)., a wholly owned foreign subsidiary of Granules India Limited for Ramelteon Tablets, 8 mg.
- Read more about Alembic Pharmaceuticals receives USFDA Final Approval for Vardenafil Hydrochloride Tablets
Alembic Pharmaceuticals Limited announced that the Company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Vardenafil Hydrochloride Tablets, 2.5 mg (base), 5 mg (base), 10 mg (base), and 20 mg (base).
- Read more about Alembic Pharmaceuticals receives USFDA Tentative Approval for Empagliflozin and Metformin Hydrochloride Tablets
- Read more about Pfizer got FDA fast track designation for two mRNA based Sars-CoV-2 vaccine
6 July 2020

FDA Approves First-Line Immunotherapy for Patients with MSI-H/dMMR Metastatic Colorectal Cancer

U.S. Food and Drug Administration approved Keytruda (pembrolizumab) for intravenous injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. This marks the first immunotherapy approved for this patient population as a first-line treatment and which is administered to patients without also giving chemotherapy.