News

(FDA) approves a label change for ADCETRIS® (brentuximab vedotin) for injection, for intravenous use.

Posted on 11.19.2018

On November 16, 2018, the U.S. Food and Drug Administration (FDA) approved a label change for ADCETRIS® (brentuximab vedotin) for injection, for intravenous use.

The new indication is as follows:

  • Adult patients with previously untreated systemic anaplastic large cell lymphoma
Read More “(FDA) approves a label change for ADCETRIS® (brentuximab vedotin) for injection, for intravenous use.”

FDA-Approved Indication for KEYTRUDA® (pembrolizumab) for the Treatment of Adult Patients With Hepatocellular Carcinoma (HCC)

Posted on 11.16.2018
Merck is pleased to announce that KEYTRUDA has been approved by the FDA for the treatment of patients with HCC who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and
Read More “FDA-Approved Indication for KEYTRUDA® (pembrolizumab) for the Treatment of Adult Patients With Hepatocellular Carcinoma (HCC)”

FDA-Approved Indication for KEYTRUDA® (pembrolizumab) Announced

Posted on 11.9.2018

Merck is pleased to announce that KEYTRUDA in combination with carboplatin and either paclitaxel or nab-paclitaxel has been approved by the FDA for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA is also indicated in combination with pemetrexed … Read More “FDA-Approved Indication for KEYTRUDA® (pembrolizumab) Announced”

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

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

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

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

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 “KEYTRUDA Approved by FDA for Treatment of Cervical Cancer”

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

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