Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.
Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., if approved
If approved, it will be the first USFDA-approved immunomodulator for the treatment of Covid-19 in hospitalised patients
If approved, Opdivo plus chemotherapy would be the first neoadjuvant immunotherapy-based option for patients with resectable non-small cell lung cancer in the U.S.
Application based on the pivotal Phase 3 TRANSFORM study in which Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years
Evrysdi is approved in 70 countries and submitted in a further 31 with more than 4,500 patients treated to date
Kymriah, the first-ever FDA-approved CAR-T cell therapy, is currently available in 30 countries in one or more indications
FDA's withholding of the PRV was contrary to law because no drug product containing phenobarbital sodium was 'previously approved'
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