FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients
If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers
This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan
Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone
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
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