regulatory

News

For the second time in less than a year, Vinay Prasad has departed from the FDA, after a string of controversial regulatory decisions.

News

Shares in PepGen fell sharply after the FDA placed a partial clinical hold on its lead drug for rare neuromuscular disease DM1.

News

The FDA has started reviewing Hansa's imlifidase for highly sensitised adults needing a kidney transplant, but not in the requested rapid timeframe.

Sales & Marketing

PPC ads often contain so little text that they avoid direct claims. Many consist only of a brand name, a link, and limited copy.

News

uniQure looks like it may have to run another trial of its Huntington's disease gene therapy AMT-130, delaying the highly anticipated programme.

R&D

As rare disease becomes more competitive, information parity is disappearing.