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GlaxoSmithKline (GSK) and Adolor stopped development of their bowel-disorder drug and withdrew an application because of increased risk of heart attacks, benign and malignant tumors and bone fractures, the companies said.
The FDA ordered companies to stop manufacturing unapproved suppository products containing trimethobenzamide hydrochloride because the drugs lack proof of efficacy.
The European Medicines Agency (EMEA) has released a draft user guide for small and midsize pharmaceutical companies aimed at enhancing awareness of the main aspects of the European Union’s medicines legislation.
The FDA is sending more than 1,100 letters to pharmaceutical companies advising them to reevaluate pharmacokinetic studies conducted by contract company MDS Pharma Services because the results may be invalid.
The FDA approved only two new drug applications (NDAs) in November, but the approval rate is up overall compared with this time in 2005, according to a report from Friedman Billings Ramsey (FBR).
The FDA issued an approvable letter for Nuvo’s topical non-steroidal anti-inflammatory drug Pennsaid to treat osteoarthritis of the knee, the company announced.
The FDA approved only two new drug applications (NDAs) in November, but the approval rate is up overall compared with this time last year, according to a report from Friedman Billings Ramsey (FBR).
Merck expects its drug development pipeline, including three expected new drug applications (NDAs) in 2007, to contribute to high earnings growth, the company announced.
October saw the highest number of drug approvals of any month in 2006, which could become a record year for drug approvals, according to research by Friedman, Billings, Ramsey (FBR). Read More