The US Food and Drug Administration (FDA) has granted fast track designation to Alvine Pharmaceuticals' ALV003 for the potential treatment of celiac disease. Alvine is at present conducting Phase 2 trials with ALV003, an orally ...
Tags: ALV003, treatment of celiac disease, orally administered mixture
Janssen-Cilag International has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) seeking conditional approval to use the investigational drug bedaquiline (TMC207) as an oral treatment, to be used as ...
Tags: investigational drug bedaquiline, multi-drug resistant tuberculosis
The US Federal Drug Administration (FDA) has received an application from Sobi for Kineret (anakinra) for the indication of neonatal-onset multisystem inflammatory disease (NOMID). The filing is made under an Orphan Drug Designation for ...
The US FDA has accepted ThromboGenics'biologics license application for ocriplasmin intravitreal injection,2.5mg/ml and granted it priority review. The company proposed the injection for the treatment of symptomatic Vitreomacular ...
Janssen Research and Development has received the Priority Review for the supplemental New Drug Application (sNDA) for ZYTIGA from US Food and Drug Administration (FDA). Zytiga (abiraterone acetate) is administered in combination with ...
Tags: sNDA, priority review, FDA
The US Food and Drug Administration (FDA) has approved ZALTRAP (ziv-aflibercept) injection to be used in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI) to treat patients with metastatic colorectal cancer (mCRC) that is ...
Tags: Zaltrap Injection, Medicine
The USFDA has accepted Exelixis' new drug application for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer and granted priority review designation. ...
Tags: FDA, new drug application, Priority Review Designation
The US FDA has granted priority review designation to Bayer HealthCare's new drug application (NDA) filed for regorafenib to treat patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard ...
Tags: US FDA, Bayer HealthCare, NDA
Astellas Pharma and Medivation have announced the submission of marketing authorization application (MAA) to the European Medicines Agency (EMA) for enzalutamide to treat metastatic castration-resistant prostate cancer in men who have ...
Tags: enzalutamide, metastatic castration-resistant prostate cancer
The US Food and Drug Administration (FDA) has approved Pfizer's Lyrica (pregabalin) capsules CV for the management of neuropathic pain associated with spinal cord injury based on priority review. The FDA approval is based on two ...
Tags: FDA approval, neuropathic pain, Lyrica, clinical researh
Exelixis has completed the submission of new drug application (NDA) for cabozantinib as a treatment for progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC) patients, with the FDA. Cabozantinib is ...
Tags: submission of new drug application, FDA, pharmaceutical product
Medivation and Astellas Pharma have announced the submission of new drug application (NDA) for enzalutamide (formerly MDV3100) to the FDA. The enzalutamide has been studied in patients with castration-resistant prostate cancer who ...
Tags: enzalutamide, new drug application, pharmaceutical product
Dynavax Technologies has submitted a US Biologics License Application (BLA) to the FDA for HEPLISAV, an investigational adult hepatitis B vaccine. In Phase III trials, HEPLISAV demonstrated higher and earlier protection with fewer ...
EpiCept has received fast track designation for AmiKet (amitriptyline 4%, ketamine 2% cream) from the US Food and Drug Administration (FDA). AmiKet is indicated for the treatment of neuropathic pain associated with ...
Tags: FDA, fast track designation, treatment of neuropathic pain
Sanofi and Regeneron Pharmaceuticals have received FDA priority review for the biologics license application (BLA) of ZALTRAP (aflibercept) as a treatment for metastatic colorectal cancer (mCRC). The filing was based on the Phase III ...