US based Ariad Pharmaceuticals has submitted New Drug Application (NDA) for its investigational BCR-ABL inhibitor, ponatinib for the approval of US Food and Drug Administration (FDA). Ponatinib is indicated for patients with resistant or ...
Tags: BCR-ABL inhibitor, CML, Ph+ALL
Novartis, Incyte's strategic collaborator, has received the European Commission approval for Jakavi (INC424, ruxolitinib), an oral JAK 1 and JAK 2 inhibitor to treat patients with myelofibrosis. The oral JAK 1 and JAK 2 inhibitor ...
Qiagen has won the US Food and Drug Administration (FDA) approval for its new molecular companion diagnostic product, therascreen KRAS RGQ PCR test kit, to provide guidance on the use of Erbitux for approximately 110,000 US patients with ...
Tags: Qiagen, FDA, molecular companion diagnostic product, test kit
Proacta, a San Diego based biotechnology company, has announced FDA approval of investigational new drug (IND) application for PR610, a hypoxia-activated irreversible multi-kinase inhibitor, for the treatment of cancer. With the IND ...
Tags: investigational new drug, IND
US Food and Drug Administration (FDA) has approved Pfizer's Bosulf (bosutinib) to treat adult patients with chronic, accelerated or blast phase Philadelphia chromosome-positive (Ph+) (CML) with resistance to prior therapy. Bosulif is a ...
Tags: bosulf, bosutinib, kinase inhibitor, Philadelphia chromosome-positive
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
The US Food and Drug Administration (FDA) has granted fast track designation for Idenix Pharmaceuticals' IDX719 to treat chronic hepatitis C infection (HCV). IDX719 is an NS5A inhibitor that demonstrated pan-genotypic activity in a recent ...
Tags: IDX719, HCV, chronic hepatitis C infection
Pfizer has received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for crizotinib to treat adults with previously treated anaplastic lymphoma kinase (ALK)-positive ...
Tags: Pfizer, CHMP, anaplastic lymphoma kinase
Janssen Research & Development has submitted a new drug application (NDA) to the FDA for canagliflozin to treat adult patients with type 2 diabetes. The filing is based on a global Phase III clinical development program, including nine ...
Tags: Janssen Research&Development, SGLT2, cardiovascular study
Takeda Pharmaceutical has received a complete response letter from the US Food and Drug Administration (FDA) regarding its new drug applications (NDAs) for alogliptin and the fixed-dose combination therapy alogliptin and pioglitazone. ...
Tags: FDA, alogliptin, clinical trial program
Abbott will expand the current CE-IVD product labeling for its Vysis ALK Break Apart FISH Probe Kit to allow the test to be marketed in the European Union as a companion diagnostic. The test uses Abbott's proprietary fluorescence in situ ...
Tags: Abbott, anaplastic lymphoma kinase, ALK, FISH technology
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
The European Commission (EC) has granted marketing authorization to Pfizer's INLYTA (axitinib) oral therapy, designed to treat adult patients with advanced renal cell carcinoma (RCC). INLYTA, a kinase inhibitor, is designed to ...
CytoDyn has entered into an agreement to purchase Progenics Pharmaceuticals' proprietary humanized monoclonal antibody HIV viral-entry inhibitor drug candidate, PRO 140, for $3.5m. Upon successful continued clinical development of PRO ...
Tags: CytoDyn, HIV viral-entry inhibitor drug, humanized monoclonal antibody
US affiliate of Merz Pharma, Merz has acquired Cuvposa (glycopyrrolate) oral solution, the only FDA approved treatment for pediatric chronic severe drooling (sialorrhea) associated with neurologic conditions such as cerebral palsy. ...
Tags: Merz Pharmaceuticals, CP, Cerebral palsy, Cuvposa