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FDA Approves Exelixis’ Cabozantinib for Advanced HCC

The FDA has approved cabozantinib (Cabometyx) as a treatment for patients with hepatocellular carcinoma (HCC) who previously received sorafenib (Nexavar), according to the company developing the therapy, Exelixis. The approval was based on findings from the phase III CELESTIAL trial, in which overall survival (OS) was improved by 2.2 months with cabozantinib versus placebo. Median...

Bristol-Myers Squibb’s Sprycel® (dasatinib) Tablets Now Approved in Combination with Chemotherapy in Certain Pediatric Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Press Release See All Press Releases      Sign up for Email Alerts      Press Release RSS Sprycel is the first and only second-generation tyrosine kinase inhibitor for pediatric patients for the treatment of newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia in combination with chemotherapy Approval marks second pediatric leukemia indication for Sprycel 1 CATEGORY:  CORPORATE/FINANCIAL NEWSWEDNESDAY, JANUARY 2, 2019 4:25 PM EST#FDA...

FDA-Approved Indication for KEYTRUDA® (pembrolizumab) for the Treatment of Adult and Pediatric Patients With Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma (MCC)

Merck is pleased to announce that KEYTRUDA has been approved by the FDA for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic MCC. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and...

NEW FDA approval- Stemline Therapeutics

Stemline Therapeutics recently announced that the Food and Drug Administration (FDA) has approved ELZONRISTM (tagraxofusp-erzs; SL-401) for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN): https://ir.stemline.com/news-releases/news-release-details/fda-approves-elzonristm-tagraxofusp-first-treatment-blastic Full prescribing information can be found here:http://elzonris.com/hcp/resources/ELZONRIS_US_Full_Prescribing_Information.pdf ELZONRISTM will not be available for shipment until late January.  We are currently in the process of finalizing a compliment of clinical and patient focused resources. ...


FDA approves olaparib for first-line maintenance of BRCA-mutated advanced ovarian cancer

On December 19, 2018, the Food and Drug Administration approved olaparib (LYNPARZA, AstraZeneca Pharmaceuticals LP) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Patients with gBRCAm advanced...

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