Topic: regulatory approvals
The gene silencing pioneer expects to complete the submission by the end of the year, setting it up to win approval in the U.S. in 2018.
Akcea sees the filing positioning it to bring the treatment of familial chylomicronemia syndrome to market in the U.S. next year.
Regulators stand accused of waving through drugs on the basis of slight data and then failing to ensure postapproval trials validate the decision.
The FDA rolled out its Digital Health Innovation Action Plan, which includes a program aimed at accelerating approval for digital health technology.
Officials at the EMA must now allay concerns their meetings with sponsors introduce a source of bias into their decision-making.
A panel of experts voted 12 to 4 in favor of approving Puma's breast cancer adjuvant therapy neratinib.
The FDA has knocked back Vernalis’ filing for approval of CCP-07, wiping 12% off the company’s stock price in early trading.
Kite Pharma completed an FDA submission for its CAR-T therapy hours before its self-imposed target passed.
FDA has granted 510(k) clearance to Bovie Medical’s revamped J-Plasma generator and handpiece.
The European Medicines Agency has recommended the approval of Blue Earth Diagnostics’ prostate cancer PET imaging agent.