Acquisition adds complementary dermatology product to the Pelthos portfolio anchored by ZELSUVMI™ Xepi is a novel FDA-approved topical treatment for impetigo that addresses a critical unmet need in antibiotic-resistant skin infections caused by staph and strep infections, most commonly affecting children Impetigo affects approximately 3 million people in the U.S. every year and is among the most common bacterial skin infections seen in pediatric offices Private convertible notes financing will s

Atacicept met the primary endpoint of reduction in proteinuria (UPCR) at week 36; participants receiving atacicept achieved a 46% reduction from baseline and 42% reduction compared to placebo at week 36 (p<0.0001) The safety profile of atacicept across the ORIGIN program appears favorable, and comparable to placebo Biologics License Application (BLA) submission through the Accelerated Approval Program to the U.S. FDA expected in Q4 2025; potential PDUFA date in 2026 ORIGIN 3 trial continues w

Nov. 06, 2025 -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisations for all four presentations

Nov. 05, 2025 -- Jupiter Neurosciences, Inc. (NASDAQ:JUNS), a clinical-stage pharmaceutical company developing JOTROL™, a patented resveratrol-based therapeutic platform targeting neuroinflammation and mitochondrial dysfunction, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 2a clinical trial of JOTROL™ in patients with Parkinson’s disease. The FDA’s clearance marks a significant regulatory milesto

Exclusive collaboration and license agreement focuses on advancing novel T cell therapy “Seed-and-Boost” approach exploiting the mechanism of the CUE-100 series of Immuno-STATs® Novel therapeutic approach is designed to enable in vivo expansion and activation of infused T cell receptor engineered T cells (TCR-Ts) to provide durability, tolerability and enhanced clinical benefit while reducing manufacturing complexity Compelling data generated in preclinical models of multiple solid tumors, inclu

Nov. 06, 2025 -- CytoMed Therapeutics Limited (NASDAQ: GDTC) (“CytoMed” or “Company”), a Singapore-based clinical stage biopharmaceutical company focused on harnessing its proprietary technologies to develop novel affordable donor-derived cell-based immunotherapies for the treatment of a broad range of cancers, including both blood and solid tumours, announced today that it secures non-dilutive investment for its subsidiary, LongevityBank Pte Ltd (“LongevityBank”) from ICH Capital Pte Ltd (“ICH

DSAP is a premalignant, progressive disease characterized by numerous expanding lesions which significantly impact quality-of-life; no FDA-approved therapies exist for the estimated more than 50,000 diagnosed U.S. patients QTORIN™ pitavastatin has the potential to be the first pathogenesis-directed therapy designed to directly inhibit the mevalonate pathway, the causal driver of DSAP, in the pathogenic skin tissue Company plans to initiate a Phase 2 trial evaluating QTORIN™ pitavastatin for DSAP

The MHRA (Medicines and Healthcare products Regulatory Agency) granted UK Marketing Authorisation for XOANACYL via the International Recognition Procedure (Route B) recognising its prior EU approval (June 2025) XOANACYL is an oral therapy designed to address two major unmet needs in CKD - Iron deficiency and elevated serum phosphorus – in a single drug AVEROA is now actively engaging strategic partners and investors to accelerate European market access and unlock XOANACYL’s full commercial poten

Nov. 04, 2025 -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces the completion of patient enrollment of SAFFRON, a global Phase III study of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) for the treatment of patients with epidermal growth factor receptor (“EGFR”)-mutated, MET-overexpressed and/or amplified, locally advanced or metastatic non-small cell lung cancer (“NSCLC”) following progression on treatment with TAGRISSO®. The last patient was randomize

Immuron receives U.S. Food and Drug administration (FDA) approval for IMM-529 Investigational New Drug (IND) application and clinical study may proceed FDA assigned an IND number (032095) for the IMM-529 application IND 32095 is Immuron’s Investigational new drug (IND) application for clinical development of IMM-529 as product to specifically prevent or treat Clostridioides difficile infection (CDI) and is now active Nov. 05, 2025 -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), is pleased to anno