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

FDA Approves Expanded Label for Merck’s KEYTRUDA®

Posted on 8.29.2018

FDA Approves Expanded Label for Merck’s KEYTRUDA® (pembrolizumab) in Combination with Pemetrexed (ALIMTA®) and Platinum Chemotherapy for First-Line Treatment of Patients with Metastatic Nonsquamous NSCLC, with No EGFR or ALK Genomic Tumor Aberrations
Approval Based on Results of KEYNOTE-189, Where … Read More

2019 Physician Fee Schedule Proposed Rule

Posted on 8.27.2018
The  2019 Medicare Physician Fee Schedule Proposed Rule with comment period  was placed on display at the Federal Register on July 12, 2018. This proposed rule updates payment policies, payment rates, and other provisions for services furnished under the Medicare
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

XTANDI Approved for Treatment of CRPC

Posted on 7.24.2018

Astellas Pharma US, Inc. and Pfizer Inc. are pleased to announce that XTANDI is now indicated for the treatment of castration-resistant prostate cancer (CRPC) patients.

 … 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