United States Health

Celcuity (NASDAQ:CELC) shares rose in premarket trading Tuesday after the U.S. Food and Drug Administration accepted the New Drug Application for gedatolisib, a potential first-in-class therapy for patients with advanced breast cancer.

Dyne Therapeutics (NASDAQ:DYN) secured a regulatory win in Asia as Japanese authorities granted orphan drug status to its lead candidate for myotonic dystrophy, providing the biotech with a clear path toward market exclusivity in the world’s third-largest pharmaceutical market.

Eli Lilly (NYSE:LLY) shares gained after the U.S. Food and Drug Administration granted Breakthrough Therapy designation to its experimental antibody-drug conjugate, potentially accelerating the path to market for a treatment targeting hard-to-treat gynecologic cancers.

Melbourne, Australia-based Telix Pharmaceuticals (NASDAQ:TLX) reported unaudited financial and operational highlights for the full year and fourth quarter ended December 31, 2025.

Novavax (NASDAQ:NVAX) shares rose in early trading after the company reached an agreement to license its vaccine-boosting technology to Pfizer (NYSE;PFE), providing a fresh source of capital for the Maryland-based biotech.

Moderna (NASDAQ:MRNA) and Merck (NYSE:MRK) announced Tuesday that their individualized neoantigen therapy continues to show dramatic long-term benefits, providing the strongest evidence to date that mRNA technology can be harnessed to treat established cancer.

Rockwell Medical (NASDAQ:RMTI) announced preliminary unaudited financial results for the fourth quarter and full-year 2025, signaling a successful operational turnaround following a year of heavy customer transition.

ImmunityBio (NASDAQ:IBRX) is moving toward a significant label expansion for its first-in-class immunotherapy, ANKTIVA® (nogapendekin alfa inbakicept), following a pivotal Type B meeting with the U.S. Food and Drug Administration (FDA).

Guardant Health (NASDAQ:GH) has secured an expansive multi-year collaboration with Merck (NYSE:MRK) to integrate its high-sensitivity liquid biopsy technology into Merck’s global oncology development program.

Immuron (NASDAQ:IMRN) achieved record first-half sales for its lead commercial product, Travelan®, reporting a 5% year-over-year increase in global revenue to AUD$4.2 million.

Mesoblast shares were in focus Monday after the company announced positive formal feedback from the U.S. Food and Drug Administration (FDA) regarding its allogeneic cell therapy, rexlemestrocel-L.

The European Medicines Agency (EMA) has officially commenced its review of ENHERTU® (trastuzumab deruxtecan) in combination with pertuzumab, a move that could soon establish the antibody-drug conjugate (ADC) as a primary treatment for HER2-positive metastatic breast cancer in the European Union.