News Releases

Ovarian Cancer Rx Receives Breakthrough Therapy Designation
BOULDER, Colo.--(BUSINESS WIRE)--Apr. 6, 2015-- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the Company’s investigational agent rucaparib as monotherapy treatment of advanced ovarian cancer in patients who have received at least two lines of prior platinum-containing therapy, with BRCA-mutated tumors, inclusive of both germline BRCA (gBRCA) and somatic BRCA (sBRCA) mutations.
Bristol-Myers Squibb and Lilly Colaborate to Evaluate Cancer Drug
NEW YORK & INDIANAPOLIS--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (NYSE:BMY) and Eli Lilly and Company (NYSE:LLY) announced today a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of Bristol-Myers Squibb's immunotherapy Opdivo (nivolumab) in combination with Lilly's galunisertib (LY2157299).
Trial on Bristol-Myers Squib Drug Stopped Early
Bristol-Myers Squibb Company (NYSE:BMY) today announced that an open-label, randomized Phase 3 study evaluating Opdivo versus docetaxel in previously treated patients with advanced, squamous cell non-small cell lung cancer (NSCLC) was stopped early.
Committee Recommends Sandoz Cancer Treatment for FDA Approval
Sandoz, a Novartis company, announced today that US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of its investigational biosimilar filgrastim in the US.
FDA Approved Somatuline Depot Injection for Pancreatic and Gastrointestinal Neuroendorcine Tumors
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that Somatuline® Depot® (lanreotide) Injection 120 mg (referred to as Somatuline®) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
Novogen Announces Breakthrough Discovery in the Treatment of Melanoma
Novogen Limited, Australian/US biotechnology company, today announces that it has confirmed that its lead candidate product, TRXE-009, originally developed for the treatment of brain cancers, has been shown in pre-clinical studies also to be highly active against melanoma.
Pfizer Announces Palbociclib PALOMA-1 Data Published in The Lancet Oncology
Pfizer Inc. (NYSE:PFE) today announced the publication of the detailed results from PALOMA-1, a randomized Phase 2 study of palbociclib in combination with letrozole versus letrozole alone, in The Lancet Oncology .
FDA Approves New Use for Xgeva
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for XGEVA® (denosumab) for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy.
FDA Grants Orphan Drug Status to Aldoxorubicin
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted multiple Orphan Drug Designations for the Company's lead drug candidate, aldoxorubicin.
FDA Grants Orphan Drug Status to Lymphoseek
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) today announced that Lymphoseek® (technetium Tc 99m tilmanocept) Injection has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for use in sentinel lymph node detection in patients with cancer of the head and neck.