FDA Grants Orphan Drug Designation to Tinostamustine for the Treatment of Malignant Glioma Purdue Pharma L.P. (“Purdue”) today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its investigational therapy tinostamustine for the…
Mirum Pharmaceuticals Spotlights Advancements in Rare Liver Disease With New Data From LIVMARLI® and Volixibat Programs at AASLD’s The Liver Meeting® 2025 Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a biotechnology company focused on developing and commercializing therapies for rare and severe…
Stoke Therapeutics Reports Third Quarter 2025 Results and Highlights Clinical and Corporate Progress Toward Transformational RNA Medicines Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechnology company pioneering the use of RNA-based medicines designed to restore healthy protein levels, announced its financial…
QIAGEN to Acquire Parse Biosciences, Expanding Portfolio into Scalable Single-Cell Sequencing and AI-Driven Discovery QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced that it has entered into a definitive agreement to fully acquire Parse Biosciences, a leading U.S.-based innovator in…
PureTech’s Gallop Oncology to Present Promising Phase 1b Data of LYT-200 in Relapsed/Refractory AML at the 2025 ASH Annual Meeting PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Company”), a biotherapeutics innovator renowned for its hub-and-spoke model that…
Kyowa Kirin International Appoints Julie Dehaene-Puype as President, Ushering in a New Era of Leadership and Growth Kyowa Kirin International (“KKI”), a regional group company of Kyowa Kirin Co., Ltd. (TSE: 4151), a leading Japan-based global specialty pharmaceutical company, has…
Health Canada Grants Authorization for LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer’s Disease In Canada, lecanemab is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment or mild dementia due to Alzheimer’s disease…
Biotech Markets Turn Positive but Experts Say Don’t Call It a Comeback—Yet M&A is back, the S&P XBI is rising again, a biotech pulled off an IPO and positive data is pulling in investors again. This may just be the…
The FDA approval marks Gazyva’s first non-oncology indication, expanding Roche’s presence into autoimmune disease treatment. The anti-CD20 antibody, developed by Roche’s Genentech along with Biogen and already approved for multiple oncology indications, is branching into autoimmune disease. Its B cell–targeting…
Tezspire Secures U.S. FDA Approval for Chronic Rhinosinusitis with Nasal Polyps, Expanding Its Reach Beyond Severe Asthma AstraZeneca and Amgen have announced that their jointly developed biologic, Tezspire (tezepelumab), has received U.S. Food and Drug Administration (FDA) approval for the…
The agreement strengthens ME Therapeutics’ next-generation in vivo CAR cell therapy platform, expanding its pipeline targeting B-cell malignancies through innovative nanobody-based technologies. ME Therapeutics Holdings Inc. (“ME Therapeutics” or the “Company”) (CSE: METX) (FSE: Q9T), a publicly listed biotechnology company…
Roche Showcases Breakthrough Sequencing by Expansion (SBX) Technology and Sets New GUINNESS WORLD RECORD™ at ASHG 2025 Roche (SIX: RO, ROG; OTCQX: RHHBY) unveiled a series of groundbreaking advancements in its Sequencing by Expansion (SBX) technology during the American Society…
