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Pfizer’s Biosimilar RETACRIT® (epoetin alfa-epbx) Approved by U.S. FDA – – – RETACRIT, the First U.S. Biosimilar Erythropoiesis-Stimulating Agent (ESA), Now Approved Across All Indications NEW YORK, N.Y., May 15 – Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) approved RETACRIT® (epoetin alfa-epbx), a biosimilar to Epogen® and Procrit® (epoetin alfa)1, for […]

Effective for dates of service on or after January 1, 2018, the Centers for Medicare and Medicaid Services (CMS) has granted BESPONSA™ (inotuzumab ozogamicin) injection for IV infusion the following temporary Healthcare Common Procedure Coding System (HCPCS) C-Code*:  C9028 – injection, inotuzumab ozogamicin, 0.1 mg This update is about an important coding change for BESPONSA.   […]

Effective for dates of service on or after January 1, 2018, the Centers for Medicare and Medicaid Services (CMS) has granted MYLOTARG™ (gemtuzumab ozogamicin) injection for IV infusion the following permanent Healthcare Common Procedure Coding System (HCPCS) J-Code*:  J9203 – injection, gemtuzumab ozogamicin, 0.1 mg We are respectfully requesting that you update your membership of […]

U.S. Food and Drug Administration today granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy.

U.S. Food and Drug Administration today approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta, a chimeric antigen receptor (CAR) T cell therapy, is the second gene […]

On September 22, 2017, the Food and Drug Administration granted accelerated approval to nivolumab (OPDIVO, Bristol-Myers Squibb Co.) for the treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib.

On September 22, 2017, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co., Inc.) for patients with recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test. Patients must have had disease progression on or after two or more prior […]

U.S. Food and Drug Administration today granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies.

U.S. Food and Drug Administration today approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.

U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML). The FDA also approved Mylotarg for the treatment of patients aged 2 years and older with CD33-positive AML who have experienced a relapse or who have […]