Keyword: Food and Drug Administration (FDA)

News

Shire to Buy Biotech Firm Dyax

04.11.2015 - Ireland-based and London-listed drugmaker Shire has agreed what is being called a “defensive” deal to buy US biotech firm Dyax, which has a breakthrough drug said to threaten one...

News

FDA Approves New Pancreatic Cancer Treatment

29.10.2015 - The US Food and Drug Administration (FDA) has approved, with reservations, the new pancreatic cancer drug Onivyde manufactured by US drugmaker Merrimack for use in combination with...

News

Imprimis Touts Cheaper Daraprim Alternative

26.10.2015 - California-based Imprimis Pharmaceuticals is touting a customizable compounded formulation of pyrimethamine and leucovorin as a low cost alternative to Daraprim, the drug that made...

News

AstraZeneca US Diabetes Launch Delayed

19.10.2015 - AstraZeneca’s US launch of a fixed-dose diabetes drug combination of saxagliptin and dapagliflozin has been delayed, due to concerns of the Food and Drug Administration (FDA). In a...

News

Merck-Pfizer Avelumab on FDA Fast Track

08.10.2015 - After previously receiving Orphan Drug status for avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody to treat the rare and aggressive skin cancer Merkel...

Plant Construction & Process Technology

Chances and Hurdles for Biosimilars

07.10.2015 - With biosimilars the pharmaceutical industry and health-care business move into a relatively young discipline with high sales potential. The follow-up drugs of biopharmaceuticals...

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Merck and Pfizer Get FDA Orphan Drug Status

30.09.2015 - An alliance of Germany’s Merck KGaA and US pharmaceuticals giant Pfizer has been granted US Food and Drug Administration (FDA) orphan drug status for its investigational cancer...

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EU Commissions Backs New GSK Asthma Drug

25.09.2015 - Following the green light from health regulator European Medicines Agency, the European Commission is expected to decide on a final approval for GlaxoSmithKline’s (GSK) injectable...