United Therapeutics (NASDAQ:UTHR) has cleared a primary safety hurdle in its ambitious effort to manufacture biological alternatives to human organs, reporting that its bioengineered external liver supported critically ill patients without serious adverse effects.
MannKind (NASDAQ:MNKD) received U.S. Food and Drug Administration approval on Monday for a critical update to the prescribing information for Afrezza, its inhaled mealtime insulin.
Biogen (NASDAQ:BIIB) and Eisai have cleared a significant regulatory hurdle as the U.S. Food and Drug Administration (FDA) accepted their supplemental Biologics License Application for a subcutaneous version of the Alzheimer’s treatment Leqembi.
Bausch Health Companies (NYSE:BHC) today announced results from its global Phase 3 RED-C clinical program evaluating amorphous-rifaximin SSD for the primary prevention of hepatic encephalopathy (HE) in adults with liver cirrhosis.
Sanara MedTech (NASDAQ:SMTI) announced preliminary unaudited financial results for the fourth quarter and full year ended December 31, 2025, along with initial guidance for 2026.
OKYO Pharma (NASDAQ:OKYO) announced that the U.S. Food and Drug Administration has authorized a single-patient expanded access Investigational New Drug application (IND 176297) for urcosimod 0.05% to treat a patient with severe neuropathic corneal pain (NCP).
ImmunityBio (NASDAQ:IBRX) reported updated Phase 2 clinical results for its novel immunotherapy combination in patients with recurrent glioblastoma, suggesting the treatment may overcome the "immune collapse" that typically follows standard cancer therapies.
Plus Therapeutics (NASDAQ:PSTV) on Thursday detailed a strategic shift toward "pivotal trial readiness," supported by a recently completed $15 million public offering designed to extend the company’s cash runway into 2027.
Janux Therapeutics (NASDAQ:JANX) shares surged as much as 12% in early trading Thursday following the announcement of a global licensing deal with Bristol Myers Squibb (NYSE:BMY) worth up to $850 million.
Abbott Laboratories (NYSE:ABT) set a confident tone for 2026, projecting a return to double-digit earnings growth and robust organic sales as it prepares to integrate a massive new cancer-diagnostics vertical.
Greenwich LifeSciences (NASDAQ:GLSI) shares jumped Thursday morning after the clinical-stage biotech announced that the U.S. Food and Drug Administration (FDA) has approved the use of its first commercially manufactured lot of GP2 vials in the ongoing FLAMINGO-01 Phase III trial.
Lexicon Pharmaceuticals (NASDAQ:LXRX) successfully completed an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration for its lead pain candidate, pilavapadin.
