The FDA has approved the TROP2-directed antibody-drug conjugate Datroway as a first-line option for triple-negative breast cancer, giving Daiichi Sankyo and AstraZeneca a leg up over their competitor Gilead. The approval marks Datroway’s third, after it secured prior approvals in certain HR-positive, HER2-negative breast cancer and lung cancer patients. The latest approval is for metastatic triple-negative breast cancer patients who aren’t candidates for checkpoint inhibitors. The decision was

May 20, 2026 -- Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that the supplemental application for MAIWEIJIAN (Denosumab Injection, R&D code: 9MW0321), which was independently developed by its wholly-owned subsidiary T-mab, has been approved by the National Medical Products Administration (NMPA) for additional indications of bone metastases from solid tumors and multiple myeloma (for the treatment of patients wit

During the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) Oral Explanation, the Company received a “negative trend” opinion for the upcoming June CHMP vote Subject to the formal CHMP vote expected in the June Meeting, the Company plans to request a re-examination procedure for the application MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET)

Gilead Sciences, Inc. (Nasdaq: GILD) today announced a renewed five-year collaboration with the World Health Organization (WHO), committing funding, strategic support and product donations to accelerate progress toward eliminating visceral leishmaniasis (VL), also known as kala-azar. VL, the second deadliest parasitic disease after malaria, is a sandfly-borne illness that attacks internal organs and can be fatal if untreated. The expanded agreement aims to improve access to life-saving diagnost

May 21, 2026 -- Genethon, the French pioneer in the discovery and development of gene therapies for rare diseases, and Ampersand Biomedicines, a Flagship Pioneering multi-product platform company developing smarter medicines that act specifically at the site of disease and nowhere else, announce an exclusive collaboration to engineer a new generation of AAV capsids with superior tissue specificity. This strategic partnership brings together two highly complementary R&D teams with synergistic sci

May 20, 2026 -- Medtronic plc (NYSE: MDT), a global healthcare technology leader, today announced its intent to acquire SPR Therapeutics, Inc. (SPR), a privately held medical technology company and a recognized leader in temporary, percutaneous peripheral nerve stimulation (PNS) therapies for chronic pain management. The transaction consists of an upfront cash payment of approximately $650 million for all the outstanding equity in SPR. The acquisition continues Medtronic's momentum in driving st

Dyne Therapeutics (Nasdaq: DYN) has announced the initiation of the Phase III FORZETTO trial of zeleciment rostudirsen (z-rostudirsen; DYNE-251) in Duchenne muscular dystrophy, with the first site now open for enrollment and a biologics license application for US accelerated approval planned for later this quarter. The FORZETTO trial is a global, randomized, double-blind, placebo-controlled Phase III study evaluating z-rostudirsen in approximately 90 ambulatory male participants aged 4 to 18 ye

In the sprawling metropolis of Houston, a new biotech has emerged to tackle the biology underlying a lung disease that has no clear cause. Oorja Bio launched yesterday afternoon with $30 million and an in-licensed, novel approach to treat idiopathic pulmonary fibrosis. Oorja’s funds come from founding investor Westlake BioPartners, according to the May 19 release. The biotech’s lead asset is ORJ-001, an activator of a receptor called β1 integrin that is key for maintaining the structure and sta

May 19, 2026 -- Myosin Therapeutics, a clinical stage biotechnology company developing innovative therapies for oncology, today announced that the first patient has been dosed in its Phase 1/2 STAR-GBM study. The trial is designed to assess safety, tolerability, pharmacokinetics, and preliminary signals of clinical activity with longitudinal imaging in adults with newly diagnosed glioblastoma (GBM). With support from the National Cancer Institute (NCI/NIH), the trial is being conducted in collab

Incyte is paying Genesis $80 million upfront to expand use of its partner’s AI platform across a broader range of drug targets, continuing the biotech’s rapid embrace of AI in drug discovery and development. Delaware-based Incyte partnered with Genesis in February 2025. That deal, which included a $30 million upfront payment, positioned the companies to collaborate on two targets and gave Incyte the option to nominate a third target for a predetermined fee. Genesis has now secured an expanded a