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Simantini Singh Deo
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Boehringer Ingelheim Achieves Phase III Survival Signal with Nerandomilast in IPF and PPF
Boehringer Ingelheim's FIBRONEER™ Phase III data predict nerandomilast could extend IPF median survival to 9.1 years, signalling a likely NDA/MAA submission.
Simantini Singh Deo
Roche Gains FDA sBLA Acceptance for Lunsumio VELO Plus Polivy in Relapsed or Refractory LBCL
FDA accepts Roche's sBLA for subcutaneous Lunsumio VELO plus Polivy in relapsed/refractory LBCL; decision expected February 2027.
Simantini Singh Deo
Nicox Secures Positive CDE Pre-Submission Feedback, Clearing Path for NCX 470 NDA in China
Nicox's China licensee Ocumension receives positive CDE pre-submission feedback for NCX 470, enabling an NDA filing shortly after the U.S. submission expected summer 2026.
Simantini Singh Deo
Allergan Gains FDA Approval for SKINVIVE by JUVÉDERM as First Injectable Targeting Neck Lines
Allergan's SKINVIVE by JUVÉDERM becomes the first FDA-cleared HA injectable for neck appearance, setting a new combination-product regulatory precedent.
Simantini Singh Deo
