- Location
priority review
"-
The EU Commission Intends to Restrict Four Additional Substances Under The RoHS2 Directive
Jan 20, 2015In mid-December, the EU Commission notified the World Trade Organization (WTO) that it intends to restrict four additional substances under the RoHS2 directive. The update will bring the number of hazardous substances listed in Annex II of ...
-
FDA Designated Isavuconazole as a QIDP
Feb 27, 2014Astellas Pharma Global Development, Inc., a subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), announced today that the U.S. Food and Drug Administration (FDA) designated isavuconazole as a Qualified Infectious Disease Product ...
-
MHLW Has Approved Takeda Pharmaceutical's NDA of Adcetris 50mg Intended to Treat Patients
Jan 21, 2014The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Takeda Pharmaceutical's new drug application (NDA) of Adcetris (brentuximab vedotin) 50mg intended to treat patients with CD30 positive relapsed or refractory hodgkin ...
-
Seattle Genetics Has Received Approval of ADCETRIS
Jan 18, 2014Seattle Genetics, Inc. (Nasdaq: SGEN) today announced that its collaborator, Takeda Pharmaceutical Company Limited (Takeda), has received approval of ADCETRIS (brentuximab vedotin) from the Japanese Ministry of Health, Labour and Welfare ...
-
FDA Has Approved GlaxoSmithKline's Use of Mekinist in Combination with Tafinlar
Jan 13, 2014The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's (GSK) use of Mekinist (trametinib) in combination with Tafinlar (dabrafenib) for the treatment of patients with unresectable melanoma or metastatic melanoma with BRAF ...
Tags: FDA, Combination Drug
-
Vedolizumab Is Under Review for The Treatment of Adults
Dec 27, 2013Takeda Pharmaceutical Company Limited ("Takeda") and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., today announced that the United States (U.S.) Food & Drug Administration (FDA) has extended the Prescription Drug User ...
Tags: Takeda Pharmaceutical Company Limited, Prescription Drug User Fee Act
-
Gilead Sciences Has Received Notice of Compliance From Health Canada
Dec 19, 2013Gilead Sciences has received notice of compliance from Health Canada for its once-daily oral nucleotide analog polymerase inhibitor Sovaldi or sofosbuvir 400mg tablets for the treatment of chronic hepatitis C or CHC infection. Sovaldi is ...
-
FDA Has Approved Sovaldi 400mg Tablets
Dec 10, 2013Gilead Sciences has announced that the US Food and Drug Administration (FDA) has approved Sovaldi (sofosbuvir) 400mg tablets, a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection ...
Tags: Gilead Sciences, Chronic Hepatitis
-
BSDI Engaged in a Positive Meeting with The US Food and Drug Administration
Dec 5, 2013BioDelivery Sciences International (BSDI) announced that it engaged in a positive meeting with the US Food and Drug Administration (FDA) regarding the clinical development program for Clonidine topical gel that will allow the program to ...
-
The FDA Has Approved Nexavar for The Treatment of Locally Recurrent or Metastatic
Nov 26, 2013Germany-based Bayer HealthCare and US-based Onyx Pharmaceuticals have announced that the US Food and Drug Administration (FDA) has approved Nexavar (sorafenib), an oral multi-kinase inhibitor, for the treatment of patients with ...
-
Alcon Has Launched Jetrea to Treat Symptomatic Vitreomacular Adhesion
Nov 25, 2013Belgium-based biopharmaceutical firm ThromboGenics has announced that its partner Alcon has launched Jetrea (ocriplasmin) for the treatment of symptomatic vitreomacular adhesion (VMA) in Canada. According to the company, Canada is the ...
Tags: Alcon, Vitreomacular Adhesion
-
Merck Secured Priority Review Status From The Us FDA for an Investigational Solution
Nov 20, 2013Merck has secured priority review status from the US Food and Drug Administration (FDA) for its new drug application (NDA) for an investigational intravenous (IV) solution formulation of its antifungal agent, Noxafil (posaconazole), ...
-
Eli Lilly and Company Has Received Priority Review Status From The FDA
Oct 25, 2013Eli Lilly and Company has received priority review status from the US Food and Drug Administration (FDA) for its ramucirumab (IMC-1121B) as a single-agent treatment for advanced gastric cancer following disease progression after initial ...
Tags: Cancer Drug, FDA Priority
-
FRX Has Received QIDP Designation for Its Ceftazidime/Avibactam Drug From FDA
Sep 17, 2013US-based pharmaceutical manufacturer and marketer Forest Laboratories (FRX) has received qualified infectious disease product (QIDP) designation for its ceftazidime/avibactam drug from the US Food and Drug Administration (FDA). Currently ...
Tags: drug, Forest Laboratories
-
Bayer and Onyx Have Announced FDA Priority Review Designation
Aug 29, 2013Bayer HealthCare and Onyx Pharmaceuticals have announced FDA priority review designation for Nexavar (sorafenib) supplemental new drug application for the treatment of radioactive iodine-refractory differentiated thyroid cancer. Nexavar ...
Tags: New Drug Application, FDA