Regulators stand accused of waving through drugs on the basis of slight data and then failing to ensure postapproval trials validate the decision.
Bluebird Bio plans to bring its gene therapies to market in Europe before the U.S., thanks to a favorable regulatory pathway.
The FDA has rejected Vernalis’ filing for approval of CCP-08, scuttling its hopes of coming to market in time for the 2017-18 cough-cold season.
President Trump is now set to sign the user fee bill into law, while the right-to-try legislation will go to the House.
The biotech made the claim in a statement disclosing legal action it has begun against the pair over alleged disclosures of confidential information.
The panel voted 12 to 1 against approving the IL-6 antibody after taking a dim view of safety data presented by J&J.
University of California starts its fightback against rival Broad Institute in their dispute over intellectual property for CRISPR-Cas9.
Mitsubishi Tanabe is to spend $1.1 billion on Parkinson’s disease biotech NeuroDerm as it looks to boost its U.S. presence and CNS pipeline.
Check out Friday's dose of biotech's news of note.
Staffers are set to move to their new digs in east London in the middle of next year, shortly the EMA is scheduled to leave a neighboring building.