Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Boehringer’s Spesolimab Wins First Approval In Rare Skin Condition

May Commercialize Therapy Alone

Executive Summary

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.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

SC146992

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel