EMA accepts MAA submission of Shionogi’s ospemifene for the treatment of VVA
27 March 2013 | By BusinessWire
Shionogi Limited announced that the EMA accepted its MAA submission for ospemifene...
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Avacta’s Optim® 1000 helps de-risk preformulation studies
27 March 2013 | By kdm communications limited
Avacta Analytical has recently undertaken preformulation studies for a new targeted secretion inhibitor (TSI)...
Merck announces FDA acceptance of BLA for investigational grass pollen allergy immunotherapy tablet
27 March 2013 | By Merck
“We are pleased to have achieved this important milestone..."
Biogen Idec’s TECFIDERA™ approved in US as a first-line oral treatment for multiple sclerosis
27 March 2013 | By Biogen Idec
The U.S. FDA has approved TECFIDERA™...
Boehringer Ingelheim and Eli Lilly and Company announce acceptance of EMA application for investigational Type 2 Diabetes treatment empagliflozin*
26 March 2013 | By Ogilvy HealthPR London
“We are pleased with the promising results..."
Gilead announces update on Phase 3 study of oral fixed-dose combination of sofosbuvir and ledipasvir for genotype 1 hepatitis C patients
26 March 2013 | By Gilead Sciences
Gilead Sciences provided an update on ION-1...
Novartis confirms growing Gilenya® clinical and real-world experience as number of patients treated increases to over 63,000
26 March 2013 | By Novartis
Latest global patient-use data...
FDA perspective published in the New England Journal of Medicine reinforces safety of Pradaxa® (dabigatran etexilate)
26 March 2013 | By Boehringer Ingelheim
A new perspective from the U.S. FDA...
XELJANZ® approved in Japan for the treatment of adults with rheumatoid arthritis
25 March 2013 | By Pfizer
“RA is a serious and disabling disease and there is a need for new treatment options..."
Regulatory update: GlaxoSmithKline receives complete response from FDA for candidate pandemic H5N1 adjuvanted influenza vaccine
25 March 2013 | By GlaxoSmithKline
GSK received a Complete Response letter...
Daiichi Sankyo receives approval in Japan for manufacture and marketing of PRALIA(R)
25 March 2013 | By Daiichi Sankyo
Approval to manufacture and market the osteoporosis treatment...
Sanofi and Transgene announce innovative long-term collaboration
25 March 2013 | By Sanofi
Creation of a new state-of-the-art industrial platform at Genzyme’s unit in Lyon...
ARIAD announces that Iclusig(TM) receives positive CHMP opinion for approval in the European Union
22 March 2013 | By Biosector 2
Positive opinion on the marketing authorization application for Iclusig™...
CHMP issues positive opinion for TECFIDERA(TM) as a first-line treatment for MS in the European Union
22 March 2013 | By GCI Health
European Commission decision anticipated in second quarter of 2013...
European CHMP adopts positive opinion for Stribild®
22 March 2013 | By Gilead Sciences
Stribild® a once-daily integrase inhibitor-based single tablet regimen for the treatment of HIV-1 infection...
