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

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

Jan. 29, 2026 -- Innovative Molecules GmbH, a German clinical stage biotech company focused on development of novel agents in the field of herpes-mediated diseases, today announced the successful completion of its Phase 1 clinical development program and the transition into Phase 2 for its oral selective helicase primase HSV inhibitor adibelivir (IM-250). The Phase 1 clinical development program included the following clinical trials: IM-101: Phase 1a single-ascending dose study in healthy volu

Jan. 29, 2026 -- Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced the first patient was dosed in its first-in-human clinical trial evaluating RMC-5127, a RAS(ON) G12V-selective inhibitor. The first-in-human trial, RMC-5127-001 [NCT07349537], is an open-label trial evaluating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of RMC-5127 as both a monotherapy and in combi

MYQORZO, a Cardiac Myosin Inhibitor, Directly Addresses Underlying Hypercontractility Associated with Obstructive HCM Jan. 27, 2026 -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that MYQORZO™ (aficamten) is now available for prescription in 5 mg, 10 mg, 15 mg and 20 mg tablets in the U.S. MYQORZO was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional ca

Designation is based on the breadth of available litifilimab data, including the Phase 2 LILAC study result that showed improvements in cutaneous lupus erythematosus (CLE) skin disease activity Litifilimab has the potential to be a first-in-class therapy targeting blood dendritic cell antigen 2 (BDCA2) in CLE, a chronic autoimmune skin disease that has a substantial impact on the daily life of patients, and may result in permanent scarring and disfigurement FDA Breakthrough Therapy Designati

Tinlarebant is the first therapeutic candidate to demonstrate clinical efficacy in Stargardt disease, having met the primary endpoint in the pivotal, global Phase 3 DRAGON trial with 36% reduction in lesion growth (p-value=0.0033) 60 adolescent STGD1 subjects enrolled in DRAGON II clinical trial across Japan, the United States, and the United Kingdom Belite Bio plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in 1H 2026 Jan. 27, 2026 -- Belite Bio, In