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13 February 2014 | By Johnson & Johnson
Janssen Biotech, Inc. announced the U.S. Food and Drug Administration has approved IMBRUVICA™ (ibrutinib) capsules for the treatment of patients with chronic lymphocytic leukemia who have received at least one prior therapy...
12 February 2014 | By Pfizer
Pfizer agrees with the recommendation of the joint meeting of the FDA Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee...
28 January 2014 | By Teva
Teva Pharmaceutical Industries Ltd. announced that the FDA has approved the Company’s supplemental new drug application for three-times-a-week COPAXONE® 40mg/mL...
24 January 2014 | By Novartis
Novartis announced it will shortly submit a revised filing package, including new data analyses, for re-examination for conditional approval of RLX030 (serelaxin) for acute heart failure...
24 January 2014 | By Daiichi Sankyo Company
Ranbaxy Laboratories Limited announced that the US FDA notified the company that it is prohibited from manufacturing and distributing active pharmaceutical ingredients from its facility in Toansa, India, for FDA-regulated drug products...
16 January 2014 | By Johnson & Johnson
Janssen is seeking approval of rivaroxaban at a proposed dose of 2.5 mg twice daily (BID) for a 90 day treatment duration...
13 January 2014 | By AstraZeneca
AstraZeneca and Bristol-Myers Squibb Company announced the FDA approved FARXIGA™ (dapagliflozin), a once-daily oral treatment indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus...
8 January 2014 | By Merck
ISENTRESS is now indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in patients four weeks of age and older...
12 December 2013 | By AstraZeneca
Advisory Committee recommends metreleptin for the treatment of paediatric and adult patients with generalised lipodystrophy...
10 December 2013 | By Novo Nordisk
The reporting relates to the company’s receipt of a Complete Response Letter from the US Food and Drug Administration...
3 December 2013 | By Boehringer Ingelheim
Boehringer Ingelheim (BI) and Eli Lilly and Company today announced new data1 from a Phase IV study evaluating linagliptin (5 mg) as monotherapy and in combination with metformin (1500 or 2000 mg) in treatment-naive adults with newly diagnosed (<12 months) uncontrolled Type 2 Diabetes (T2D).
2 December 2013 | By Biogen Idec
Biogen Idec announced that the U.S. Food and Drug Administration has extended the initial Prescription Drug User Fee Act date for its review of the Biologics License Application for ALPROLIX...
25 November 2013 | By GlaxoSmithKline
The U.S. Food and Drug Administration has eased restrictions on patient access to Avandia (rosiglitazone)...
25 November 2013 | By GlaxoSmithKline
GlaxoSmithKline plc announced that the FDA has approved its pandemic Influenza A Virus Monovalent Vaccine...
22 November 2013 | By Johnson & Johnson
OLYSIO™ works by blocking the viral protease enzyme that enables the hepatitis C virus (HCV) to replicate in host cells...
