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It has approved the application for dolutegravier 10 milligram and 25 milligram oral tablets, reducing the weight limit to at least 30 kilograms from at least 40 kilograms,

The drugs Dr Reddy’s is acquiring are being sold by Teva to secure US antitrust clearance for its $40.5bn acquisition of Allergan’s generic drugs portfolio. The agreement includes

TD-1473 is specifically designed to penetrate the intestinal wall and act directly at the site of inflammation with minimal systemic exposure. Data from the study demonstrated TD-1473 to

The transaction is conditioned on the close of sufficient financing to fund the operations of the combined company, and due diligence review. FPMI intends to execute the transaction

The sNDA for the 72 mcg dose of linaclotide is based on efficacy and safety data from a double-blind, placebo-controlled Phase III clinical trial of 1,223 adult patients

The Phase 1 trial will be conducted in normal healthy volunteers. Initiation of this trial is based on encouraging pre-clinical results, including data presented last year at the

On January 25, 2016, Valeant announced that the FDA had accepted for review the Biologics License Application (BLA) submitted by AstraZeneca (LSE/SSE/NYSE: AZN) in partnership with Valeant for

Isavuconazole is an intravenous and oral triazole antifungal indicated for the treatment of adult patients with invasive aspergillosis and adult patients with mucormycosis for whom amphotericin B is

The company said its decision was based on evidence of tumour-inhibiting activity from early pre-clinical trials with the technology. GBM accounts for 16% of all diagnosed brain cancers