GlaxoSmithKline (GSK) has announced FDA approval of raxibacumab anti-toxin as a combination therapy along with antibacterial drugs for the treatment of inhalational anthrax in both adult and pediatric patients with limited treatment ...
SRI International has received a new grant from the National Institute of Allergy and Infectious Diseases (NIAID) to develop a topical microbicide gel for drug delivery. The topical microbicide gel, which will be based on a patented ...
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
Pfizer has won US FDA approval for its rheumatoid arthritis (RA) therapy, Xeljanz (tofacitinib citrate) 5mg twice daily, indicated for patients who failed to respond to methotrexate. Xeljanz can be used as a single treatment regime or as ...
Tags: Pfizer, tofacitinib citrate, Xeljanz
Furiex Pharmaceuticals said Takeda Global Research & Development Center has resubmitted New Drug Applications (NDAs) to the US Food and Drug Administration (FDA) for alogliptin and fixed-dose combination therapy alogliptin and pioglitazone ...
Tags: Furiex Pharmaceuticals, NDAs, alogliptin and pioglitazone
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
Janssen Research & Development company has submitted bedaquiline (TMC207) new drug application (NDA) to the US Food and Drug Administration (FDA) for approval. Bedaquiline,an investigational drug administered orally,is used as part of ...
Tags: FDA, new drug application, investigational drug, pulmonary
The US FDA has approved Novo Nordisk Victoza (liraglutide [rDNA] injection) label to include data showing superior blood sugar control and weight reduction when compared to Januvia (sitagliptin). Label update also includes approval of ...
Tags: Label update, type 2 diabetes, Victoza
Mylan, a pharmaceutical company, has introduced lamivudine film coated tablets, 150mg and 300mg, in the UK and Italy. The generic version of GlaxoSmithKline's Epivir tablets is indicated as part of antiretroviral (ARV) combination therapy ...
Tags: Generic Epivir Tablets, lamivudine film coated tablets, HIV-infected
Catalent Pharma Solutions has signed a supply agreement with Vivus to supply Qsymia capsules, a proprietary combination phentermine and extended-release topiramate. Catalent Modified Release Technologies president Ian Muir said Catalent ...
Tags: Qsymia capsules, extended-release topiramate, combination therapy
VentiRx Pharmaceuticals has formed a world-wide collaboration with Celgene Corporation to develop VTX-2337, a highly potent and selective TLR8 agonist for cancer treatment. As part of the agreement, Celgene will fund $35m as upfront ...