July 14, 2026 -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the US Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for a once weekly lecanemab irmb subcutaneous injection (US brand name: Leqembi Iqlik®) as a starting dose for the treatment of early Alzheimer's disease. The US launch is planned for late August 2026. Leqembi Iqlik is a first-of-its-kind anti-amyloid treatment worldwide, offering at-home d

GSK reported interim findings Monday for PD-1 inhibitor Jemperli (dostarlimab), which met its primary endpoint in a registrational trial involving patients with stage II/III mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer. The UK pharma is planning to share the data with global regulators, including in the US, where the antibody may benefit from a speedy review. The single-arm Phase II AZUR-1 trial enrolled 154 patients to receive nine cycle

The FDA assigned a PDUFA target action date of February 28, 2027 If approved, AD109 has the potential to become the first oral pharmacologic therapy designed to address the neuromuscular root cause of upper airway collapse for the millions of people living with OSA July 14, 2026 -- Apnimed, Inc., a late stage clinical pharmaceutical company dedicated to the discovery, development, and commercialization of novel oral therapies that address the neurobiology of sleep-related breathing diseases, t

July 14, 2026-- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") today announced that it has entered into a collaboration with Memorial Sloan Kettering Cancer Center (MSKCC) to advance a Phase II clinical study evaluating a cadonilimab-based combination regimen for the perioperative treatment of locally advanced, resectable HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Cadonilimab is the world's first PD-1/CTLA-4 bispecific antibody developed by Akeso. The study is be

Application based on long-term safety and efficacy data from three ongoing studies, including adult height and additional clinical outcomes beyond linear growth, including body proportionality and arm span evaluated over long-term follow-up FDA PDUFA target action date of Feb. 28, 2027 July 13, 2026 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) for V

Boehringer Ingelheim’s Jascayd (nerandomilast) tablets have been granted marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat adults with idiopathic pulmonary fibrosis (IPF) and adults with progressive pulmonary fibrosis (PPF). Jascayd is the first treatment of its kind licensed for use in IPF and PPF in adults. The MHRA authorisation is based on the results of the pivotal phase 3 clinical trials involving 1,177 and 1,176 patients with IPF and PPF r

July 10, 2026 -- SL Science Holding Limited (“SL Science” or the “Company”) (Nasdaq: SLBT), a Taiwan-headquartered biomedical company specializing in developing innovative cellular and gene therapies, today announced that the Company has submitted an Orphan Drug Designation (ODD) request to the U.S. Food and Drug Administration (FDA) for its Gamma Delta T (GDT) cell therapy product, Vdelta2+ Gamma Delta T Cells, for the treatment of glioblastoma multiforme (GBM). The FDA's Office of Orphan Produ

July 13, 2026 -- Delonix Bioworks, a clinical-stage biotechnology company pioneering genetically engineered bacterial vaccines, today announced that the first participant has been dosed in its Phase 1 clinical trial of DX-104 in China. DX-104 is an innovative Group B meningococcal (MenB) vaccine candidate developed using the company's proprietary OMV Plus® platform. This milestone marks a significant step in the concurrent global development of DX-104, following the initiation and ongoing progre

On July 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) each in combination with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment (before surgery) followed by adjuvant treatment after cystectomy (surgery to remove the bladder) for adults with muscle invasive bladder cancer (MIBC). This extends the prior approval for the regimen in this setting from patients who ar

Findings demonstrate significant improvements in major disruptive menopausal symptoms and a beneficial increase in E2/E1 ratio July 9, 2026 -- Elysium Health, Inc.™, the leading longevity science company, today announced new research published in Frontiers in Aging demonstrating significant improvements in disruptive menopausal symptoms in women taking Basis™, the company's flagship product clinically proven to raise NAD+ levels. The study also showed a significant increase in the ratio of estr