Initiation of the IIMPACT study follows promising Phase 1 results where Restem-L demonstrated clinically meaningful efficacy and a significant reduction in steroid use within 6 months in Idiopathic Inflammatory Myopathy (IIM) Interim readout expected in 2H 2026 Feb. 03, 2026 -- RESTEM – a clinical-stage biotechnology company that develops off-the-shelf, next-generation cell therapies designed to modulate the immune system, today announced it had dosed the first patient in the Phase 2/3 IIMPACT

GTB-5550 Phase 1 dose escalation basket trial expected to initiate mid-2026 Phase 1 protocol allows multiple solid tumor types known to express B7-H3 Unaudited proforma cash balance as of January 31, 2026 of approximately $9 million anticipated to extend cash runway through Q4 2026 Feb. 03, 2026 -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary TriKE® natural killer (NK

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Biogen’s litifilimab (BIIB059) for cutaneous lupus erythematosus (CLE), a chronic autoimmune skin condition. This designation aims to expedite the development and review of medicines for serious conditions. The FDA based its decision on comprehensive data, including findings from the Phase II LILAC study. Results from this trial indicated that litifilimab reduced skin disease activity in patients with CLE

Februari 2, 2026 - Immedica today announces the results from a phase 3 clinical study Loargys® in children below 2 years of age with arginase 1 deficiency (ARG1-D). ARG1-D is an autosomal recessive urea cycle disorder (UCD) characterized by chronic hyperargininemia, leading to progressive spasticity, developmental delay, and seizures. Available treatment before Loargys involved a strict protein-restricted diet, essential amino acid supplementation, and symptom management. Despite these interven

Feb. 2, 2026 -- Global pharma major Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced the launch of Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, in the United States, following the approval for its Abbreviated New Drug Application (ANDA) from the U.S. FDA. The product was developed in partnership with Pharmascience Inc. Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg are bioequivalent to Sprycel® Tabl

Feb. 2, 2026 -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, today announced that the U.S Food and Drug Administration's (FDA) Office of Orphan Products Development has granted Orphan Drug Designation (ODD) to IFx-2.0 for the treatment of stage IIB to stage IV cutaneous melanoma. The ODD designation was based on data from the Company's previously completed Phase

Ultragenyx has resubmitted its approval request for a rare disease gene therapy after the FDA rejected it last summer. UX111 is an AAV gene therapy designed to treat Sanfilippo syndrome type A. The company is again seeking accelerated approval using a novel biomarker, part of a push by biopharma to test the FDA’s appetite to ease access for rare disease drugs. But in July, the agency turned down the drug after an inspection of a manufacturing facility raised concerns. Ultragenyx said Friday th

-Incyte (Nasdaq:INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC). "Today’s positive CHMP opinion is an important step

Data identify nuclear PD-L1 as a previously unaddressed driver of immunotherapy resistance and metastatic progression Jan. 30, 2026 -- Kazia Therapeutics (NASDAQ: KZIA), an oncology-focused pharmaceutical company developing novel therapies for difficult-to-treat cancers, today announced compelling preclinical and translational data supporting the development of NDL2, a potentially first-in-class protein degrader that is designed to selectively eliminate nuclear PD-L1, a previously unrecognized

Jan. 29, 2026 -- MicuRx Pharmaceuticals, Inc. ("MicuRx"), a clinical-stage biopharmaceutical company focused on developing novel anti-infective therapies for drug-resistant bacterial infections, recently announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for MRX-5, enabling the company to initiate a Phase 2a clinical trial in patients with Mycobacterium abscessus pulmonary disease. M. abscessus pulmonary disease is a serious an