News

Genentech announces FDA Approval of ROZLYTREK

Posted on 9.10.2019

Genentech is excited to share the news of a new FDA approval. ROZLYTREK™ (entrectinib) is now FDA approved for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive.

ROZLYTREK is also FDA … Read More

FDA grants approval for POLIVY™

Posted on 9.10.2019

On June 10, 2019, the US Food and Drug Administration (FDA) granted accelerated approval for POLIVY™ (polatuzumab vedotin-piiq) in combination with bendamustine and rituximab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise … Read More

Merck announces new FDA approval for KEYTRUDA

Posted on 8.22.2019

Merck is pleased to announce that KEYTRUDA has been approved by the FDA for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 [combined positive score (CPS) ≥10] as … Read More

US Food and Drug Administration approves INREBIC® for Treatment

Posted on 8.21.2019

INREBIC® (fedratinib) capsules, a product from Celgene, is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).

INDICATION

INREBIC® (fedratinib) is indicated for the treatment of adult … Read More

KEYTRUDA approved by FDA for first-line treatment of patients with HNSCC

Posted on 6.19.2019

Merck is pleased to announce that KEYTRUDA, in combination with platinum and fluorouracil (FU), has been approved by the FDA for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA … Read More

(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-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
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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

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