A preliminary interim analysis from a late-stage study of Merck & Co.'s Welireg (belzutifan) in earlier-stage clear cell renal cell carcinoma (RCC) showed that the oral HIF-2α inhibitor significantly boosting disease-free survival (DFS) when combined with the PD-1 inhibitor Keytruda (pembrolizumab) as adjuvant therapy following nephrectomy. The latest readout — building on findings highlighted last October — prompted a priority review by the FDA, with a target action date of June 19. The LITESP

March 01, 2026 -- InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company for the treatment of cancer and autoimmune diseases, announced today that its next generation TRK inhibitor zurletrectinib (ICP-723) has been granted priority review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), for the treatment of pediatric patients (aged 2 to 12) with solid tumors harboring NTRK gene fusions. Priority review is one of the key policies in

If approved, Dupixent would be the first targeted medicine in the EU indicated for children aged 2 to 11 years with CSU inadequately controlled by standard-of-care antihistamine treatment CSU is a chronic skin disease with underlying type 2 inflammation that can cause debilitating hives and recurring itch in young children Feb. 27, 2026 -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Us

Feb. 27, 2026 -- Cipla USA Inc. the wholly owned subsidiary of Cipla Limited(BSE: 500087; NSE: CIPLA; and hereafter referred to as "Cipla") today announced the launch of Liraglutide Injection, 18 mg/3 mL (6 mg/mL) single–patient–use prefilled pens, the generic equivalent of Saxenda® (liraglutide injection). This milestone builds on the recent Abbreviated New Drug Approval (ANDA) by United States Food & Drugs Administration (USFDA) obtained by its partner, Orbicular, for Liraglutide Injection(ge

Feb. 27, 2026 -- Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative positron emission tomography (PET) radiopharmaceuticals, today announced results from the first head-to-head study comparing urinary bladder radioactivity between two prostate-specific membrane antigen (PSMA)-targeted PET radiopharmaceuticals. This prospective, multicenter, intra-patient comparison evaluated urinary radioactivity and lesion detection rates of POS

Breakthrough Therapy designation granted based on interim NGN-401 Phase 1/2 data demonstrating clinically meaningful, durable and multidomain functional improvements On track to complete dosing in Embolden™ registrational trial of NGN-401 in second quarter of 2026 Plans to present additional interim Phase 1/2 clinical data in mid-2026 Neurogene Inc. (Nasdaq: NGNE), a clinical-stage company founded to bring life-changing genetic medicines to patients and families affected by rare neurological

Dosing of Cohort 1 complete with first three patients having received starting dose of JAG201 delivered via intracerebroventricular (ICV) injection First two patients in dose-escalation Cohort 2 have been dosed, and company anticipates target enrollment and dosing to be completed in Cohort 2 in Q2 2026No treatment-related serious adverse events (SAEs) or dose-limiting toxicities (DLTs) have been reported to dateEarly indications of clinical benefit observed in neurodevelopmental domains, incl

Cartography Biosciences, Inc., a clinical-stage biotechnology company advancing a differentiated pipeline of antibody-based cancer therapies, today announced that the first patient has been dosed in a Phase 1 clinical trial evaluating CBI-1214, the company’s lead investigational therapy targeting LY6G6D in adults with microsatellite stable or microsatellite instability-low (MSS/MSI-L) colorectal cancer (CRC). LY6G6D is selectively expressed in CRC, making it a compelling therapeutic target with

HekaBio K.K., (Headquarters: Chuo-ku, Tokyo) announces that the innovative solid tumor treatment device ‘Alpha DaRT (Diffusing Alpha Radiation Therapy),’ developed by Alpha Tau Medical Ltd. (Headquarters: Jerusalem, Israel) has received official approval in Japan. HekaBio led the approval process as the Designated Marketing Authorization Holder (DMAH) and will be responsible for launching the product in the Japanese market.With this approval, Japan becomes the first country in the world outside

IntraBio Inc. today announced that a positive opinion recommending Orphan Medicinal Product Designation for Acetylleucine for the treatment of CACNA1A disorders has been granted by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA). The European Commission is expected to grant the designation in Q2 2026. CACNA1A-related disorders are rare, genetic neurological conditions characterized by progressive impairment in coordination, balance, speech, and overall