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Clinical trial results showed that the treatment induced and maintained clinical remission in a significantly higher proportion of adult patients compared to a placebo. Read More
CDER Director Janet Woodcock called for an overhaul of American drug manufacturing to offset the nation’s dependence on APIs made in China, India and elsewhere, in remarks on Wednesday to a House subcommittee. Read More
An FDA advisory committee voted 14 to two on Wednesday to recommend FDA approval of Agile Therapeutics’ birth control patch AG 200-15 (levonorgestrel/ethinyl estradiol). Read More
The U.S. Patent Trial and Review Board has invalidated an Antecip Bioventures patent for neridronic acid as a treatment for complex regional pain syndrome (CRPS). Read More
ICER found that in combination with aspirin, Xarelto reduced the risk of cardiovascular death, stroke or heart attack in patients with stable cardiovascular disease. Read More
Eleven drugmakers agreed to pay the state of Illinois $242 million to settle a 2005 lawsuit over the wholesale prices of their prescription drugs. Read More
The FDA outlined new electronic submission requirements for sponsors of investigational new drug applications (INDs) that apply to certain IND safety reports, in a draft guidance released on Tuesday. Read More