Boehringer’s Spesolimab Wins First Approval In Rare Skin Condition
May Commercialize Therapy Alone
The German firm’s monoclonal antibody has received a US thumbs-up for a severe skin disease with high unmet need but it must address diagnostic and educational hurdles.
You may also be interested in...
Keeping Track: US FDA Novel Approvals Return With Xenpozyme, Spevigo Nods; Stimufend Survives COVID-19 Delays
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
AnaptysBio’s Imsidolimab Meets Yet Another Failure
The company is discontinuing the drug’s development in hidradenitis suppurativa after a Phase II flop, leaving GPP as the only viable indication, for which it is planning to out-license the drug.
Will 2022 Be US FDA’s Year Of ‘No’? Approval Rate For Novel Agents Plunged In First Half
With 19 novel approvals and 14 complete response letters in the first half of 2022, the year is shaping up to be a turnabout from the big approval counts and rare CRLs of the recent approvals boom years.