Integrated biopharmaceutical company ThromboGenics has obtained Health Canada approval for Jetrea (ocriplasmin) for the treatment of symptomatic vitreomacular adhesion (VMA). Launch of the drug in Canada will be conducted by Alcon, ...
Genentech, a member of the Roche Group, has obtained FDA priority review status for Obinutuzumab (GA101) to treat previously untreated chronic lymphocytic leukemia (CLL). The FDA has also accepted the company's biologics license ...
Tags: Genentech, FDA Priority
The US Food and Drug Administration (FDA) has given its clearance to Amgen's XGEVA (denosumab) to treat adult or skeletally mature patients suffering from giant cell tumor of bone (GCTB). Approved after conducting a priority review, XGEVA ...
Tags: Amgen's XGEVA, Medicine
Biopharmaceutical company Gilead Sciences has obtained priority review status for Sofosbuvir new drug application (NDA) from the FDA for the treatment of hepatitis C infection (HCV). The investigational product is an oral nucleotide ...
Tags: Gilead, Sofosbuvir NDA
The USFDA has granted priority review designation for investigational agent Metreleptin, jointly developed by Bristol-Myers Squibb Company and AstraZeneca, for the treatment of metabolic disorders associated with rare forms of ...
Celgene International has obtained FDA priority review status for Abraxane (paclitaxel protein-bound particles for injectable suspension) supplemental new drug application (sNDA). The application covers the use of Abraxane and gemcitabine ...
Tags: Celgene sNDA, FDA Priority
The US FDA has approved Xofigo (radium Ra 223 dichloride) for the treatment of symptomatic late-stage (metastatic) castration-resistant prostate cancer spread to bones but not to other organs in men. The therapy is indicated for men whose ...
Cubist Pharmaceuticals has received the US Food and Drug Administration (FDA) fast track status for its late-stage antibiotic candidate ceftolozane/tazobactam in the previously granted Qualified Infectious Disease Product (QIDP) ...
Tags: Cubist, Fast Track Status
The USFDA has accepted Otsuka Pharmaceutical's new drug application (NDA) of tolvaptan for priority review to treat autosomal dominant polycystic kidney disease (ADPKD). The filing was based on Phase III clinical trial results of the drug ...
Tags: Otsuka Tolvaptan NDA, Medicine
The USFDA has granted priority review designation to ViiV Healthcare's dolutegravir as a candidate with the potential to treat HIV infection in combination with other antiretroviral agents, in adolescents and adults. The dolutegravir new ...
Tags: infection therapy, Healthcare, FDA
The USFDA has accepted for filing Astellas Pharma's supplemental new drug application (sNDA) for Tarceva (erlotinib) tablets for a genetically distinct form of advanced lung cancer. Astellas is seeking approval to use Tarceva as the ...
Braeburn, a subsidiary of Apple Tree Partners, has gained commercialization rights to Titan Pharmaceuticals' long-acting subdermal implant in the US and Canada, under the signed license agreement. The investigational subcutaneous implant, ...
Tags: Braeburn, Marketing Rights, subsidiary of Apple Tree Partners, Medicine
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
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 ...
GlaxoSmithKline (GSK), Ligand Pharmaceuticals' partner, has gained FDA priority review status for the supplemental new drug application for Promacta to treat thrombocytopenia in adult patients with chronic hepatitis C virus infection. ...
Tags: GlaxoSmithKline, GSK, promacta, thrombocytopenia