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A new draft guidance from the FDA encourages drugmakers to speed up development of Hepatitis D treatments for use in the U.S., offering recommendations for innovative trial designs, target populations and endpoints. Read More
Acting FDA Commissioner Ned Sharpless ends his six-month stint at the agency today, and the White House is expected to nominate oncologist Stephen Hahn to fill the permanent role. Read More
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