News

AstraZeneca announces FDA approval of LUMOXITITM for the treatment of certain adult patients

Posted on 9.18.2018

AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has approved LUMOXITITM (moxetumomab pasudotox-tdfk), a first-in-class CD22-directed cytotoxin, for the treatment of adult patients with relapsed or refractory hairy … Read More

Opdivo® (nivolumab) Receives FDA Approval for Certain Patients with Previously Treated Small Cell Lung Cancer

Posted on 8.17.2018

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) as the First New Medication in Nearly 20 Years for Certain Patients with Previously Treated Small Cell Lung Cancer

(BMS) Aug 17, 2018 – Bristol-Myers Squibb Company today announced that Opdivo (nivolumab) … Read More

U.S. FDA Approves Pfizer’s Biosimilar NIVESTYM™

Posted on 7.23.2018

U.S. FDA Approves Pfizer’s Biosimilar NIVESTYM™
(filgrastim-aafi)
Release Date:
Friday, July 20, 2018 4:24 pm EDT
Terms:
Dateline City:
NEW YORK
NIVESTYM™, a biosimilar to Neupogen ® (filgrastim), is Pfizer’s fourth
biosimilar to be approved by the FDA
NEW YORK–(BUSINESS … Read More

Keytruda RECEIVES FDA APPROVAL for the Treatment of Refractory Relapsed Primary Mediastinal Large B-Cell Lymphoma in Adult and Pediatric Patients

Posted on 6.27.2018

FDA Approved for the Treatment of Refractory or Relapsed Primary Mediastinal Large B-Cell Lymphoma in Adult and Pediatric Patients

Merck is pleased to announce that KEYTRUDA® (pembrolizumab) is indicated for the treatment of adult and pediatric patients with refractory Read More

KEYTRUDA Approved by FDA for Treatment of Cervical Cancer

Posted on 6.25.2018

Merck is pleased to announce that KEYTRUDA® (pembrolizumab) has been approved by the US FDA for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express programmed death ligand Read More

Rubraca® (rucaparib) Approved in the U.S. as Maintenance Treatment of Recurrent Ovarian Cancer

Posted on 5.29.2018

Rubraca® (rucaparib) Approved in the U.S. as Maintenance Treatment of
Recurrent Ovarian Cancer
• Rubraca is now indicated as maintenance treatment for women with recurrent ovarian
cancer who are in a complete or partial response to platinum-based chemotherapy,
regardless of … Read More

Pfizer’s Biosimilar RETACRIT® (epoetin alfa-epbx) Approved by U.S. FDA

Posted on 5.23.2018

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.) … Read More

Acalabrutinib

Posted on 11.1.2017

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.… Read More

Axicabtagene Ciloleucel

Posted on 10.19.2017

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 … Read More

Nivolumab

Posted on 9.29.2017

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.… Read More