Delcath Systems has submitted its proprietary chemosaturation delivery system's new drug application (NDA) to the US Food and Drug Administration (FDA). The application includes the use of chemosaturation system along with melphalan ...
Tags: FDA, NDA, medical application
Paris based cancer center Institut Curie has ordered four radiotherapy treatment systems - three Varian TrueBeam systems and a Novalis Tx machine - from Varian Medical Systems. The cancer institute has purchased the devices to replace ...
Tags: radiotherapy treatment system, medical device, clinical research
Affibody has entered into a collaboration agreement with GE Healthcare to develop a Her2-targeted PET imaging agent for detecting breast and gastric cancer. The clinical trials for the Her2-targeted PET imaging agent is scheduled to ...
Tags: company cooperation, clinical research, breast cancer, gastric cancer
Medivation and Astellas Pharma have announced FDA approval for Xtandi (enzalutamide) capsules to treat metastatic castration-resistant prostate cancer in patients with previously received docetaxel. Medivation and Astellas expect to make ...
Tags: Medivation, Astellas, FDA
Janssen's Zytiga indicated for metastatic castration-resistant prostate cancer(mCRPC),has won FDA approval for use in patients who have not received chemotherapy. The oral,once-daily medication was previously used in combination with ...
AstraZeneca and US Food and Drug Administration (FDA) have agreed to update label for Faslodex (fulvestrant) injection. The updated prescribing information for Faslodex US contains results and a Kaplan-Meier plot of the final overall ...
Tags: AstraZeneca, Faslodex injection label, US, FDA
Biopharmaceutical company AstraZeneca has announced agreement with the US Food and Drug Administration (FDA) with regard to FASLODEX (fulvestrant) Injection label changes. The labeling update includes results and a Kaplan-Meier plot of ...
Tags: FASLODEX Injection label, AstraZeneca, prescription medicines
Roche Group member, Genentech has received US Food and Drug Administration (FDA) official approval of priority review designation for trastuzumab emtansine Biologics License Application (BLA). Trastuzumab Emtansine is designed to treat ...
Multinational biopharmaceutical company Celgene has received US Food and Drug Administration (FDA) approval for Abraxane, which is aimed to treat locally advanced or metastatic non-small cell lung cancer in combination with carboplatin in ...
Tags: Abraxane, lung cancer, Multinational biopharmaceutical company Celgene
Tokai Pharmaceuticals has gained FDA fast track designation for galeterone (TOK-001) for the potential treatment of metastatic castration-resistant prostate cancer (CRPC). Galeterone disrupts androgen receptor (AR) signaling, the key ...
Tags: galeterone, TOK-001, castration-resistant prostate cancer, CRPC
Bayer HealthCare has filed a new drug application (NDA) with the FDA seeking approval for the oral multi-kinase inhibitor regorafenib to treat patients with metastatic colorectal cancer (mCRC). The company has even filed an application ...
Tags: oral multi-kinase inhibitor regorafenib, metastatic colorectal cancer
Dako, a manufacturer of cancer diagnostics solutions, has received approval from the US Food and Drug Administration to market HercepTest and Her2 Fish pharmDx kit as co diagnostics for pertuzumab (Perjeta), a Genentech cancer drug. ...
Tags: Dako, HER2-positive metastatic breast cance, HER2 FISH pharmDx Kit
Bayer HealthCare has submitted has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its regorafenib drug. The oral multi-kinase inhibitor regorafenib is used for the treatment of metastatic and ...
Tags: NDA, FDA, inhibitor, metastatic, GIST
Medivation and Astellas Pharma have launched Xtandi (enzalutamide) capsules for patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. Xtandi, an oral, once-daily androgen receptor inhibitor ...
Pfizer Canada has announced the availability of Xalkori (crizotinib) for patients with anaplastic lymphoma kinase (ALK)-positive advanced or metastatic non-small cell lung cancer (NSCLC) in Canada. A validated ALK assay should be used to ...
Tags: ALK, ALK-positive lung cancer, Pfizer Canada