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.
Sanofi might only get the US go-ahead for its dengue vaccine Dengvaxia in a narrow population, leaving the door open for its rival Takeda.
Others hoping to get FDA approvals include Sage Therapeutics and Novartis, but hopes look dimmer for Lexicon and Sanofi.
Incredibly, a US FDA panel has left the door open for approval of Karyopharm’s selinexor in multiple myeloma, despite concerns about safety.
DBV plans to refile Viaskin Peanut in the third quarter, but things look all but smooth.