The US Food and Drug Administration (USFDA) has accepted the Biologics License Application (BLA) for FYB206 for review. To the best of the companies' knowledge, this is the first publicly announced acceptance by the USFDA of a filing for a proposed biosimilar to Keytruda®. FYB206 was developed without a comparative Phase III efficacy trial, following a development pathway agreed upon with the USFDA in early 2025. Zydus holds exclusive commercialization rights for the United States and Canada and

Proof of concept demonstrated for first-in-class oral therapy, addressing multiple aspects of atopic dermatitis pathology and with the potential to deliver lasting benefit to patients SYX-5219 was safe and well-tolerated over the six-week treatment period Clinically meaningful and statistically significant improvements over placebo demonstrated across key measures of atopic dermatitis disease activity including EASI score, PP-NRS (itch score) and vIGA at day 43 Significant correlation of change

Oct. 12, 2026 -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the U.S. Food and Drug Administration (FDA) has granted its investigational new drug (IND) application for AK0406, a long-acting antiviral drug-Fc conjugate (AFC), enabling the company to initiate a phase II clinical trial for influenza prevention in general population in the United States. Seasonal vaccination remains central to influenza prevention. However, changes in circulating influenza viruses and va

DTI-117 induced defecation within minutes of intramuscular injection in conscious minipigs, with responder rates rising with dose, and confirmed in a crossover study Pharmacokinetic profile of rapid absorption and fast clearance, with a mean terminal half-life of approximately 3 to 4 minutes, is consistent with a short-acting effect DTI-117 is being evaluated in a NIH-funded randomized, double-blind, placebo-controlled Phase 1 single-ascending-dose study October 13, 2026 – Dignify Therapeutics

-- Launch follows MHLW approval of IMCIVREE for acquired hypothalamic obesity and inclusion on Japan's National Health Insurance drug price list -- -- IMCIVREE is the first approved therapy in Japan for patients living with acquired hypothalamic obesity -- Oct. 13, 2026 -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced the commercial launch of

Mean weight reduction ranged from 1.5% to 3.2% at Day 29 across Cohorts 1-4, compared with 0.1% for pooled placebo. No severe or serious TEAEs, no TEAE-related dose modifications, and no TEAE-related discontinuations among all BMF-650-treated MAD participants. A rapid one-step titration to the target dose of 400 mg QD in Cohort 5 was equally well tolerated with all TEAEs being mild, with nausea and vomiting each reported in only 12.5% of participants, supporting further evaluation of “no titrati

Preclinical study shows 1.5- to 2-hour increase in total sleep time as Company advances toward clinical development and attracts Chris Brearley, M.D., as Chief Medical Officer Oct. 14, 2026 -- Carnyx Therapeutics Ltd. (" Carnyx" or the " Company"), a preclinical-stage biopharmaceutical company developing first-in-class molecular therapeutics for sleep and retinitis pigmentosa, today unveiled CNYX-005, its lead oral sleep candidate, alongside preclinical findings showing increased total sleep ti

A spin-out focused on AI-enabled decoding of the deliverome Proprietary synthetic biology platform identifies conjugates that target RNA medicines beyond the liver, with initial focus on renovascular disease Round co-led by 4BIO Capital and IQ Capital, with participation from Verve Ventures, Harel Tech, Entree Capital, Kerna Ventures and Saras Capital Undecimal Bio (“Undecimal”), a platform biotechnology company advancing targeted delivery of siRNA therapeutics, today announced an oversubscribe

Oct. 13, 2026 -- Rona Therapeutics today announced it has granted Roche (SIX: RO, ROG; OTCQX: RHHBY) an exclusive worldwide license for Rona's investigational RNAi candidate targeting activin receptor-like kinase 7 (ALK7) utilizing the company's proprietary extrahepatic delivery platform. ALK7, encoded by the ACVR1C gene, is predominantly expressed in adipose tissue and is a genetically validated target for obesity and metabolic diseases. Inhibition of ALK7 by directly targeting adipocytes has

Oct. 12, 2026 -- Xodus Medical, a leading developer and manufacturer of innovative surgical safety solutions, today announced that it has entered into an agreement to be acquired by STERIS, a global provider of products and services that support patient care with an emphasis on infection prevention. The acquisition represents a significant milestone in Xodus Medical's more than 30-year history, bringing together two organizations with a shared commitment to advancing patient safety, supporting