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The FDA has shot down three citizen petitions seeking agency action on biosimilar labeling, arguing that a draft guidance issued in April is sufficient to address most of their concerns. Read More
With strong pipelines in Europe, Japan and the U.S., regenerative medicine is poised to become a $68 billion market in the next four years, according to a new report. Read More
The House Energy and Commerce Committee advanced a bill that would grant priority review vouchers to companies that develop counterterrorism therapies. Read More
With an eye toward advancing personalized medicine, the FDA is mapping out the development of therapies with companion devices, offering companies a slew of pathways. Read More
The FDA is recommending that companies conducting clinical trials on bacterial vaginosis drugs exclude patients with herpes simplex or human papilloma virus, one of dozens of recommendations the agency made on the subject Thursday. Read More
A measure to incentivize the development of abuse-deterrent opioids skated through the Senate on Wednesday, with its next stop being the White House. Read More