Greenwich LifeSciences (NASDAQ:GLSI) provided a comprehensive year-end update on Monday for its pivotal Phase III clinical trial, FLAMINGO-01.
The trial is evaluating GLSI-100, a Fast Track-designated immunotherapy designed to prevent breast cancer recurrence in HER2-positive patients.
KalVista Pharmaceuticals (NASDAQ:KALV) has received marketing and manufacturing approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for EKTERLY (sebetralstat), establishing it as the first and only oral on-demand treatment for hereditary angioedema (HAE) in the country.
Alvotech (NASDAQ:ALVO) achieved a significant milestone in the competitive biologics market on Monday, announcing the European debut of Gobivaz, the first biosimilar to the blockbuster inflammatory drug Simponi to reach the market anywhere in the world.
AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo have secured their tenth Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration for ENHERTU, marking a pivotal step in moving the blockbuster treatment into earlier, potentially curative stages of breast cancer.
Incyte Biosciences Japan G.K. has secured regulatory clearance from Japan’s Ministry of Health, Labour and Welfare for Minjuvi, marking the first time a dual-targeted CD19 and CD20 immunotherapy combination has been authorized for patients with follicular lymphoma in the country.
Samsung Biologics, the world’s leading contract development and manufacturing organization, has reached an agreement to acquire Human Genome Sciences from GSK (NYSE:GSK), marking the South Korean firm’s first physical manufacturing footprint in the United States.
Telix Pharmaceuticals (NASDAQ:TLX) moved closer to expanding its global footprint in precision medicine on Sunday, reporting successful Phase 3 results for its flagship prostate cancer imaging agent in China and clearing regulatory hurdles for its broader pipeline in the United States.
Outlook Therapeutics (NASDAQ:OTLK) reported its fiscal 2025 results for the year ended September 30, 2025, revealing a net loss of $62.4 million ($1.79 per share) and $1.4 million in revenue from the initial European sales of LYTENAVA in June 2025.
Spero Therapeutics (NASDAQ:SPRO) announced today that its development partner, GSK (NYSE:GSK), has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tebipenem HBr, a treatment for complicated urinary tract infections (cUTI), including pyelonephritis.
BioMarin Pharmaceutical (NASDAQ:BMRN) and Amicus Therapeutics (NASDAQ:FOLD) announced today that BioMarin has entered into a definitive agreement to acquire Amicus for $14.50 per share in an all-cash transaction.
Psyence BioMed (NASDAQ:PBM) announced that it has received approval from the Bellberry Human Research Ethics Committee to use its psilocybin product, NPX5, in its ongoing Phase IIb clinical trial for adjustment disorder in cancer patients.
Evaxion (NASDAQ:EVAX) announced today that MSD has opted not to exercise its option to develop the protein-based version of Evaxion’s Gonorrhea vaccine candidate, EVX-B2.
