More data with voxelotor shouldn’t hurt the project’s bid for accelerated approval, but there are still doubts about its effect on a harder patient outcome.
Approvals for new uses of old drugs should far outweigh nods for novel projects in June.
Manufacturing issues prompt the US regulator to knock back projects from Nabriva and Heron Therapeutics, both of which insist that the problems are easily solvable.
The upcoming American Academy of Neurology meeting could provide clues on how the market will shake out.
May looks to be a fairly quiet month for US drug approvals, though Novartis's gene therapy should make headlines.
An Icer report questioning the cost effectiveness of Aimmune and DBV's peanut allergy projects is yet another reason to be cautious about the companies'…
A regulatory misstep puts Zogenix even further behind its epilepsy rival GW Pharma, which in turn is waiting for data that could give it another boost.
Notable US regulatory decisions due in April feature a major pipeline hope from Abbvie, a non-opioid pain medication from Heron and Glaxo’s two-pill HIV regimen.
As approval decisions near, further data fail to answer lingering questions about Esperion's bempedoic acid and Amarin's Vascepa.