Keyword: Food and Drug Administration (FDA)

Markets & Companies

Evolution of a Dynamic Healthcare Market

08.05.2014 - Changing Roles - China's far-reaching presence in the manufacture and supply of active pharmaceutical ingredients (APIs) around the world has long been known. However, with the...

News

Actavis Sues FDA Over Generic of Pfizer’s Celebrex

29.04.2014 - Generics producer Actavis has sued the U.S. Food and Drug Administration, challenging its decision to award exclusive rights to Israel's Teva to sell a generic version of Pfizer's...

News

India’s Sun Pharmaceutical to Buy Compatriot Ranbaxy

09.04.2014 - Sun Pharmaceutical Industries, India's largest drugmaker by market value, has agreed to buy compatriot generics manufacturer Ranbaxy Laboratories for $3.2 billion from Daiichi...

News

GSK Combined Melanoma Treatment Delayed in Europe

28.03.2014 - GlaxoSmithKline (GSK), the UK's largest pharmaceutical company, has provisionally withdrawn its marketing authorization application to the European Medicines Agency (EMA) for the...

News

Lilly-Boehringer Diabetes Drug Halted by FDA

10.03.2014 - In response to an application by U.S. drugmaker Eli Lilly for approval of a New Drug Application (NDA) for its type 2 diabetes treatment empagliflozin, the U.S. Food and Drug...

News

Generic Drugmakers Ramp up Campaign Against FDA Label Plan

03.03.2014 - Generic drugmakers are actively campaigning against a rule proposed by the U.S. Food and Drug Administration (FDA) that would require them to change the prescribing information on...

News

Drug Maker Boehringer Facing U.S. Lawsuits

20.02.2014 - German pharmaceutical producer Boehringer Ingelheim is being confronted in the U.S. with more than 2,000 lawsuits related to its blood thinner Pradaxa (dabigatran). The plaintiffs...

News

Daiichi Sankyo Pledges “Bold Action” on Ranbaxy Ban

04.02.2014 - Japan's Daiichi Sankyo said it would send personnel to help resolve problems at a production facility of its drugmaking subsidiary Ranbaxy at Toansa in India's northern state of...