The US FDA was established in 1931, but only three years ago did it get the power to order drug makers to conduct safety studies of products that have already been approved and put into general use.
Just how difficult it is going to be to use that ...
The US FDA has announced an "ongoing safety review" of oral bisphosphosphonates to see if they are potentially linked to atypical subtrochanteric femur fractures, or fractures in the bone just below the hip joint. For the data reviewed to date, ...
PTC Therapeutics and Genzyme 's ataluren, an experimental nonsense mutation suppressor, has failed in nonsense mutation Duchenne/Becker Muscular Dystrophy (nmDBMD), show top-line Phase IIb results. Around 10-15% of DBMD cases are due to nonsense ...
Development of Roche and Biogen Idec 's humanised anti-CD20 monoclonal antibody ocrelizumab for rheumatoid arthritis (RA) has been halted after patients in clinical trials suffered serious opportunistic infections, some of which were fatal. The drug ...
The Federal Court of Australia has ordered Merck & Co to pay A$287,912 ($259,400) plus interest to a 59 year-old man who suffered a heart attack after taking the arthritis pain relief drug Vioxx (rofecoxib), in the first such trial outside the ...
